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Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

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ClinicalTrials.gov Identifier: NCT00844649
Recruitment Status : Completed
First Posted : February 16, 2009
Results First Posted : December 11, 2013
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Interventions Drug: Albumin-bound paclitaxel (ABI-007)
Drug: Gemcitabine
Enrollment 861
Recruitment Details Participants were randomized in a 1:1 ratio and the randomization was stratified by geographic region (Australia versus Eastern Europe versus Western Europe versus North America), Karnofsky performance status (70 to 80 versus 90 to 100), and by the presence of liver metastases (yes versus no)
Pre-assignment Details 38 participants were randomized but not treated due to the participants request to withdraw after the randomization results became known. 1 participant was randomized to Gemcitabine and was treated with Albumin-bound paclitaxel ABI-007/Gemcitabine in error and analyzed as treated and included in the intent to treat population (ITT)
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem) Gemcitabine (Gem)
Hide Arm/Group Description Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
Period Title: Overall Study
Started 431 [1] 430 [1]
Treated Population 421 [2] 402 [2]
Completed 26 [3] 12 [3]
Not Completed 405 418
Reason Not Completed
Progressive Disease             196             245
Adverse Event             128             73
Physician Decision             25             18
Protocol Violation             10             6
Withdrawal by Subject             28             39
Other             7             10
Withdrew prior to starting treatment             11             27
[1]
Started = Intent to Treat Population and includes all randomized participants
[2]
Treated population = all randomized patients who received at least one dose of study drug
[3]
Completed = participants remaining on treatment at the time of the data cut off 17 Sept 2012
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine Total
Hide Arm/Group Description

ABI-007 125 mg/m^2 administered in combination with gemcitabine 1000 mg/m^2 weekly for 3 weeks followed by one week of rest.

Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m^2 administered in combination with Gemcitabine 1000 mg/m^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest

Gemcitabine, 1000 mg/m^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).

Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

 Total of all reporting groups
Overall Number of Baseline Participants 431 430 861
Hide Baseline Analysis Population Description
For the Karnofsky Performance Status (KPS) baseline characteristic, some of the participants did not have a baseline KPS recorded by the clinical site.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 431 participants 430 participants 861 participants
61.4  (10.70) 63.0  (9.27) 62.2  (10.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 430 participants 861 participants
Female
186
  43.2%
173
  40.2%
359
  41.7%
Male
245
  56.8%
257
  59.8%
502
  58.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 430 participants 861 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
8
   1.9%
9
   2.1%
17
   2.0%
Native Hawaiian or Other Pacific Islander
1
   0.2%
0
   0.0%
1
   0.1%
Black or African American
16
   3.7%
16
   3.7%
32
   3.7%
White
378
  87.7%
375
  87.2%
753
  87.5%
More than one race
25
   5.8%
26
   6.0%
51
   5.9%
Unknown or Not Reported
3
   0.7%
4
   0.9%
7
   0.8%
Karnofsky Performance Status (KPS)   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 431 participants 430 participants 861 participants
100% = normal, no complaints, no signs of disease 69 69 138
90% = normal activity, few symptoms of disease 179 199 378
80% = normal activity, some symptoms of disease 149 128 277
70% = caring for self, unable to work 30 33 63
60% = needs help, can manage most tasks 2 0 2
50% = needs help often and medical care 0 0 0
40% = disabled; requires special care & assistance 0 0 0
30% = severely disabled; death is imminent 0 0 0
20% = hospitalized; requires supportive treatment 0 0 0
10% = Moribund, fatal processes progressing fast 0 0 0
0% = Dead 0 0 0
[1]
Measure Description: The Karnofsky Performance Status Scale (KPS) was designed to measure the level of participant activity and medical care requirements. A general measure of participant independence and has been widely used as a general assessment of participants with cancer. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. The primary purpose of its development was to allow physicians to evaluate a participant's ability to survive chemotherapy for cancer. Two participants from the Albumin bound paclitaxel arm and one from the Gemcitabine arm did not have KPS performed.
Pancreatic Primary Tumor Location   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 431 participants 430 participants 861 participants
Head 191 180 371
Body 132 136 268
Tail 105 110 215
Unknown = not specified 3 4 7
[1]
Measure Description: Main location or area of the pancreas where the disease is detected at diagnosis. Unknown location refers to disease area not being specified.
Number of Baseline Lesions (Target + Non-Target)   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 431 participants 430 participants 861 participants
1 1 0 1
2 32 25 57
3 7 7 14
4 37 43 80
5 8 8 16
>5 276 262 538
[1]
Measure Description: Target lesions are those measurable at baseline and are generally the largest lesions, most reliably measured and most representative of the participants sites of disease. Non target lesions are all of the sites of disease present at baseline not classified as target lesions. They include bone and cystic lesions and pleural/pericardial effusion/ascites. The Independent Radiology Reviewers (IRR) only evaluated scans for those with baseline and follow-up scans.
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
Time Frame From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population (ITT population) consisted of all randomized participants.
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Hide Arm/Group Description:
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
Overall Number of Participants Analyzed 431 430
Median (95% Confidence Interval)
Unit of Measure: months
8.5
(7.89 to 9.53)
6.7
(6.01 to 7.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albumin-bound Paclitaxel (ABI-007)/Gemcitabine, Gemcitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was based on a stratified log-rank test stratified by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis
Method Stratified Log-rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.617 to 0.835
Estimation Comments Hazard ratio of Albumin bound paclitaxel + gemcitabine/gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.
2.Secondary Outcome
Title Progression-free Survival (PFS) by Independent Radiological Review (IRR)
Hide Description Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.
Time Frame Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population (ITT population) consisted of all randomized participants.
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Hide Arm/Group Description:
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
Overall Number of Participants Analyzed 431 430
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(4.47 to 5.95)
3.7
(3.61 to 4.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albumin-bound Paclitaxel (ABI-007)/Gemcitabine, Gemcitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was based on a stratified log-rank test by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis (yes vs no)
Method Stratified Log-rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .69
Confidence Interval (2-Sided) 95%
0.581 to 0.821
Estimation Comments Hazard ratio of Albumin bound paclitaxel + gemcitabine / gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.
3.Secondary Outcome
Title Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
Hide Description Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Time Frame Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population (ITT population) consisted of all randomized participants.
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Hide Arm/Group Description:
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
Overall Number of Participants Analyzed 431 430
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23
(19.1 to 27.2)
7
(5.0 to 10.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albumin-bound Paclitaxel (ABI-007)/Gemcitabine, Gemcitabine
Comments PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Response Rate Ratio
Estimated Value 3.19
Confidence Interval (2-Sided) 95%
2.178 to 4.662
Estimation Comments Response rate ratio: albumin-bound paclitaxel + gemcitabine /gemcitabine alone
4.Other Pre-specified Outcome
Title Participants With Treatment Emergent Adverse Events (AE)
Hide Description A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.
Time Frame Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patient population
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Hide Arm/Group Description:
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
Overall Number of Participants Analyzed 421 402
Measure Type: Number
Unit of Measure: participants
At least 1 AE 417 395
≥ 1 Treatment related AE (TEAE) 403 371
At least 1 Serious Adverse Event (SAE) 212 172
≥ 1 treatment related SAE 121 53
≥ 1 Grade (GR) 3/4 AE 370 298
≥ 1 Grade 3 or higher AE 374 303
≥ 1 AE leading to stopping treatment 149 95
≥ 1 AE leading to death 18 18
≥ 1 AE leading to dose reduction of ABI-007 or Gem 209 125
≥ 1 AE related dose interruption of ABI-007 or Gem 11 10
≥ 1 AE related dose delay of ABI-007 or Gem 276 192
5.Other Pre-specified Outcome
Title Number of Participants With Dose Reductions
Hide Description The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Time Frame Maximum time on treatment was 666 days
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Population
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem) Gemcitabine (Gem)
Hide Arm/Group Description:
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
Overall Number of Participants Analyzed 421 402
Measure Type: Number
Unit of Measure: participants
At least 1 alumbin bound paclitaxel dose reduction 172 0
At least 1 Gemcitabine dose reduction 198 132
6.Other Pre-specified Outcome
Title Number of Participants With Dose Interruptions
Hide Description The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Time Frame Maximum time on treatment was 666 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, includes participants who received at least one study treatment
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Hide Arm/Group Description:
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
Overall Number of Participants Analyzed 421 402
Measure Type: Number
Unit of Measure: participants
≥ 1 Albumin-bound paclitaxel dose interruption 2 0
At least 1 Gemcitabine dose interruption 8 9
7.Other Pre-specified Outcome
Title Number of Participants With Dose Delays/Doses Not Given
Hide Description The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.
Time Frame Up to 666 days
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Population
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Hide Arm/Group Description:
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
Overall Number of Participants Analyzed 421 402
Measure Type: Number
Unit of Measure: number of dose delays
At least 1 ABI-007 dose delay/Not given 300 0
At least ≥ 1 Gem dose delay/Not given 295 230
Time Frame Day 1 up to 30 days after the last dose (a maximum of 666 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Hide Arm/Group Description Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
All-Cause Mortality
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   212/421 (50.36%)   172/402 (42.79%) 
Blood and lymphatic system disorders     
Febrile neutropenia † 1  11/421 (2.61%)  2/402 (0.50%) 
Anaemia † 1  9/421 (2.14%)  2/402 (0.50%) 
Neutropenia † 1  4/421 (0.95%)  1/402 (0.25%) 
Pancytopenia † 1  3/421 (0.71%)  0/402 (0.00%) 
Haemolytic uraemic syndrome † 1  2/421 (0.48%)  1/402 (0.25%) 
Leukopenia † 1  2/421 (0.48%)  0/402 (0.00%) 
Haemorrhagic anaemia † 1  1/421 (0.24%)  0/402 (0.00%) 
Thrombocytopenia † 1  1/421 (0.24%)  3/402 (0.75%) 
Thrombotic thrombocytopenic purpura † 1  1/421 (0.24%)  0/402 (0.00%) 
Leukocytosis † 1  0/421 (0.00%)  2/402 (0.50%) 
Cardiac disorders     
Cardiac failure congestive † 1  3/421 (0.71%)  1/402 (0.25%) 
Atrial Fibrillation † 1  2/421 (0.48%)  3/402 (0.75%) 
Myocardial Infarction † 1  2/421 (0.48%)  1/402 (0.25%) 
Acute coronary syndrome † 1  1/421 (0.24%)  0/402 (0.00%) 
Atrial tachycardia † 1  1/421 (0.24%)  0/402 (0.00%) 
Cardiac arrest † 1  1/421 (0.24%)  3/402 (0.75%) 
Cardiogenic shock † 1  1/421 (0.24%)  0/402 (0.00%) 
Angina unstable † 1  0/421 (0.00%)  1/402 (0.25%) 
Cardiopulmonary Failure † 1  0/421 (0.00%)  1/402 (0.25%) 
Myocardial ischaemia † 1  0/421 (0.00%)  1/402 (0.25%) 
Pericardial effusion † 1  0/421 (0.00%)  1/402 (0.25%) 
Eye disorders     
Visual acuity reduced † 1  1/421 (0.24%)  0/402 (0.00%) 
Gastrointestinal disorders     
Vomiting † 1  18/421 (4.28%)  12/402 (2.99%) 
Abdominal Pain † 1  11/421 (2.61%)  10/402 (2.49%) 
Nausea † 1  11/421 (2.61%)  8/402 (1.99%) 
Diarrhoea † 1  9/421 (2.14%)  3/402 (0.75%) 
Ascites † 1  4/421 (0.95%)  5/402 (1.24%) 
Intestinal obstruction † 1  4/421 (0.95%)  1/402 (0.25%) 
Small intestinal obstruction † 1  4/421 (0.95%)  1/402 (0.25%) 
Duodenal Obstruction † 1  3/421 (0.71%)  2/402 (0.50%) 
Colitis † 1  2/421 (0.48%)  0/402 (0.00%) 
Ileus † 1  2/421 (0.48%)  0/402 (0.00%) 
Pancreatitis † 1  2/421 (0.48%)  0/402 (0.00%) 
Upper gastrointestinal haemorrhage † 1  2/421 (0.48%)  0/402 (0.00%) 
Abdominal pain upper † 1  1/421 (0.24%)  0/402 (0.00%) 
Colitis Ischaemic † 1  1/421 (0.24%)  1/402 (0.25%) 
Faecaloma † 1  1/421 (0.24%)  0/402 (0.00%) 
Gastrooesophageal reflux disease † 1  1/421 (0.24%)  1/402 (0.25%) 
Impaired gastric empyting † 1  1/421 (0.24%)  0/402 (0.00%) 
Intestinal perforation † 1  1/421 (0.24%)  1/402 (0.25%) 
Melaena † 1  1/421 (0.24%)  0/402 (0.00%) 
Mesenteric vein thrombosis † 1  1/421 (0.24%)  0/402 (0.00%) 
Obstruction gastric † 1  1/421 (0.24%)  1/402 (0.25%) 
Oesophageal varices haemorrhage † 1  1/421 (0.24%)  0/402 (0.00%) 
Pancreatic cyst rupture † 1  1/421 (0.24%)  0/402 (0.00%) 
Pancreatic pseudocyst † 1  1/421 (0.24%)  0/402 (0.00%) 
Regurgitation † 1  1/421 (0.24%)  0/402 (0.00%) 
Colitis microscopic † 1  0/421 (0.00%)  1/402 (0.25%) 
Haematemesis † 1  0/421 (0.00%)  1/402 (0.25%) 
Large Intestine perforation † 1  0/421 (0.00%)  1/402 (0.25%) 
Pancreatic haemorrhage † 1  0/421 (0.00%)  1/402 (0.25%) 
Small intestinal haemorrhage † 1  0/421 (0.00%)  1/402 (0.25%) 
Splenic artery aneurysm † 1  0/421 (0.00%)  1/402 (0.25%) 
Constipation † 1  5/421 (1.19%)  6/402 (1.49%) 
Duodenal stenosis † 1  0/421 (0.00%)  1/402 (0.25%) 
Gastric haemorrhage † 1  0/421 (0.00%)  1/402 (0.25%) 
Gastrointestinal haemorrhage † 1  0/421 (0.00%)  6/402 (1.49%) 
General disorders     
Pyrexia † 1  27/421 (6.41%)  9/402 (2.24%) 
Oedema peripheral † 1  6/421 (1.43%)  3/402 (0.75%) 
Asthenia † 1  3/421 (0.71%)  5/402 (1.24%) 
Fatigue † 1  3/421 (0.71%)  2/402 (0.50%) 
General physical health deterioration † 1  2/421 (0.48%)  1/402 (0.25%) 
Chills † 1  1/421 (0.24%)  1/402 (0.25%) 
Mucosal inflammation † 1  1/421 (0.24%)  0/402 (0.00%) 
Multi-organ failure † 1  1/421 (0.24%)  1/402 (0.25%) 
Pain † 1  1/421 (0.24%)  2/402 (0.50%) 
Systemic inflammatory response syndrome † 1  1/421 (0.24%)  0/402 (0.00%) 
Device occlusion † 1  0/421 (0.00%)  2/402 (0.50%) 
Face oedema † 1  0/421 (0.00%)  1/402 (0.25%) 
Localised oedema † 1  0/421 (0.00%)  3/402 (0.75%) 
Non-cardiac chest pain † 1  0/421 (0.00%)  1/402 (0.25%) 
Sudden death † 1  0/421 (0.00%)  2/402 (0.50%) 
Adverse drug reaction † 1  1/421 (0.24%)  0/402 (0.00%) 
Generalized oedema † 1  0/421 (0.00%)  1/402 (0.25%) 
Hepatobiliary disorders     
Cholangitis † 1  10/421 (2.38%)  5/402 (1.24%) 
Bile duct obstruction † 1  4/421 (0.95%)  3/402 (0.75%) 
Jaundice † 1  4/421 (0.95%)  1/402 (0.25%) 
Hyperbilirubinaemia † 1  2/421 (0.48%)  1/402 (0.25%) 
Cholecystitis † 1  1/421 (0.24%)  0/402 (0.00%) 
Cholecystitis acute † 1  1/421 (0.24%)  1/402 (0.25%) 
Hepatic function abnormal † 1  1/421 (0.24%)  0/402 (0.00%) 
Hepatotoxicity † 1  1/421 (0.24%)  0/402 (0.00%) 
Cholangitis acute † 1  0/421 (0.00%)  1/402 (0.25%) 
Gallbladder perforation † 1  0/421 (0.00%)  1/402 (0.25%) 
Hepatic cirrhosis † 1  0/421 (0.00%)  1/402 (0.25%) 
Hepatic failure † 1  0/421 (0.00%)  1/402 (0.25%) 
Jaundice cholestatic † 1  4/421 (0.95%)  3/402 (0.75%) 
Infections and infestations     
Pneumonia † 1  17/421 (4.04%)  11/402 (2.74%) 
Cellulitis † 1  8/421 (1.90%)  5/402 (1.24%) 
Sepsis † 1  5/421 (1.19%)  5/402 (1.24%) 
Septic Shock † 1  4/421 (0.95%)  5/402 (1.24%) 
Bacterial Sepsis † 1  3/421 (0.71%)  0/402 (0.00%) 
Lower Respiratory tract infection † 1  3/421 (0.71%)  2/402 (0.50%) 
Catheter site infection † 1  2/421 (0.48%)  0/402 (0.00%) 
Clostridium difficile colitis † 1  2/421 (0.48%)  1/402 (0.25%) 
Klebsiella bacteraemia † 1  2/421 (0.48%)  0/402 (0.00%) 
Liver Abscess † 1  2/421 (0.48%)  3/402 (0.75%) 
Neutropenic sepsis † 1  2/421 (0.48%)  0/402 (0.00%) 
Bacteraemia † 1  1/421 (0.24%)  0/402 (0.00%) 
Biliary sepsis † 1  1/421 (0.24%)  0/402 (0.00%) 
Bronchitis † 1  1/421 (0.24%)  0/402 (0.00%) 
Cellulitis of male external genital organ † 1  1/421 (0.24%)  0/402 (0.00%) 
Clostridial infection † 1  1/421 (0.24%)  1/402 (0.25%) 
Device related infection † 1  1/421 (0.24%)  0/402 (0.00%) 
Escherichia bacteraemia † 1  1/421 (0.24%)  0/402 (0.00%) 
Gastroenteritis † 1  1/421 (0.24%)  1/402 (0.25%) 
Gastroenteritis viral † 1  1/421 (0.24%)  0/402 (0.00%) 
Infection † 1  1/421 (0.24%)  0/402 (0.00%) 
Laryngitis † 1  1/421 (0.24%)  0/402 (0.00%) 
Lung Infection † 1  1/421 (0.24%)  0/402 (0.00%) 
Oral Candidiasis † 1  1/421 (0.24%)  0/402 (0.00%) 
Perirectal abscess † 1  1/421 (0.24%)  0/402 (0.00%) 
Pneumonia bacterial † 1  1/421 (0.24%)  0/402 (0.00%) 
Pneumonia primary atypical † 1  1/421 (0.24%)  0/402 (0.00%) 
Postoperative wound infection † 1  1/421 (0.24%)  0/402 (0.00%) 
Pseudomonal sepsis † 1  1/421 (0.24%)  0/402 (0.00%) 
Skin Infection † 1  1/421 (0.24%)  0/402 (0.00%) 
Tooth abscess † 1  1/421 (0.24%)  0/402 (0.00%) 
Tooth Infection † 1  1/421 (0.24%)  0/402 (0.00%) 
Urosepsis † 1  1/421 (0.24%)  0/402 (0.00%) 
Biliary abscess † 1  0/421 (0.00%)  1/402 (0.25%) 
Breast cellulitis † 1  0/421 (0.00%)  1/402 (0.25%) 
Gastroenteritis clostridial † 1  0/421 (0.00%)  1/402 (0.25%) 
Infected dermal cyst † 1  0/421 (0.00%)  1/402 (0.25%) 
Klebsiella sepsis † 1  0/421 (0.00%)  1/402 (0.25%) 
Lung infection pseudomonal † 1  0/421 (0.00%)  1/402 (0.25%) 
Streptococcal bacteraemia † 1  0/421 (0.00%)  1/402 (0.25%) 
Perihepatic abscess † 1  1/421 (0.24%)  0/402 (0.00%) 
Injury, poisoning and procedural complications     
Urinary Tract Infection † 1  6/421 (1.43%)  1/402 (0.25%) 
Accidental overdose † 1  1/421 (0.24%)  1/402 (0.25%) 
Fall † 1  1/421 (0.24%)  1/402 (0.25%) 
Post procedural haemorrhage † 1  1/421 (0.24%)  0/402 (0.00%) 
Subdural haematoma † 1  1/421 (0.24%)  0/402 (0.00%) 
Cervical vertebral fracture † 1  0/421 (0.00%)  1/402 (0.25%) 
In-stent coronary artery restenosis † 1  0/421 (0.00%)  1/402 (0.25%) 
Investigations     
Liver Function test abnormal † 1  2/421 (0.48%)  0/402 (0.00%) 
Alanine aminotransferase increased † 1  1/421 (0.24%)  1/402 (0.25%) 
Blood alkaline phosphatase increased † 1  1/421 (0.24%)  0/402 (0.00%) 
Gamma-glutamyltransferase increased † 1  1/421 (0.24%)  0/402 (0.00%) 
Haemoglobulin decreased † 1  1/421 (0.24%)  0/402 (0.00%) 
Platelet count decreased † 1  1/421 (0.24%)  0/402 (0.00%) 
Transaminases increased † 1  1/421 (0.24%)  0/402 (0.00%) 
Aspartate aminotransferase increased † 1  0/421 (0.00%)  1/402 (0.25%) 
Heart rate increased † 1  0/421 (0.00%)  1/402 (0.25%) 
Neutrophil count decreased † 1  0/421 (0.00%)  1/402 (0.25%) 
Weight decreased † 1  0/421 (0.00%)  1/402 (0.25%) 
Blood bilirubin increased † 1  1/421 (0.24%)  1/402 (0.25%) 
Metabolism and nutrition disorders     
Dehyration † 1  20/421 (4.75%)  12/402 (2.99%) 
Decreased Appetite † 1  5/421 (1.19%)  0/402 (0.00%) 
Hyperkalaemia † 1  0/421 (0.00%)  3/402 (0.75%) 
Hyponatraemia † 1  2/421 (0.48%)  1/402 (0.25%) 
Diabetic ketoacidosis † 1  1/421 (0.24%)  1/402 (0.25%) 
Failure to thrive † 1  1/421 (0.24%)  0/402 (0.00%) 
Hyperglycaemia † 1  1/421 (0.24%)  0/402 (0.00%) 
Hypoglycaemia † 1  1/421 (0.24%)  3/402 (0.75%) 
Hypoalbuminaemia † 1  0/421 (0.00%)  1/402 (0.25%) 
Hypovolaemia † 1  0/421 (0.00%)  1/402 (0.25%) 
Pseudohyponatraemia † 1  0/421 (0.00%)  1/402 (0.25%) 
Hypokalaemia † 1  2/421 (0.48%)  0/402 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/421 (0.24%)  0/402 (0.00%) 
Musculoskeletal pain † 1  1/421 (0.24%)  1/402 (0.25%) 
Musculoskeletal chest pain † 1  1/421 (0.24%)  0/402 (0.00%) 
Back pain † 1  0/421 (0.00%)  1/402 (0.25%) 
Joint swelling † 1  0/421 (0.00%)  1/402 (0.25%) 
Muscular weakness † 1  0/421 (0.00%)  1/402 (0.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign anorectal neoplasm † 1  1/421 (0.24%)  0/402 (0.00%) 
Malignant ascites † 1  1/421 (0.24%)  0/402 (0.00%) 
Metastatic pain † 1  1/421 (0.24%)  0/402 (0.00%) 
Tumour associated fever † 1  1/421 (0.24%)  0/402 (0.00%) 
Lymphangiosis carcinomatosa † 1  0/421 (0.00%)  1/402 (0.25%) 
Meningioma benign † 1  0/421 (0.00%)  1/402 (0.25%) 
Pancreatic carcinoma metastatic † 1  0/421 (0.00%)  1/402 (0.25%) 
Nervous system disorders     
Cerebral ischaemia † 1  2/421 (0.48%)  2/402 (0.50%) 
Peripheral motor neuropathy † 1  2/421 (0.48%)  0/402 (0.00%) 
Autonomic nervous system imbalance † 1  1/421 (0.24%)  0/402 (0.00%) 
Cerebral infarction † 1  1/421 (0.24%)  0/402 (0.00%) 
Cerebrovascular accident † 1  1/421 (0.24%)  5/402 (1.24%) 
Dizziness † 1  1/421 (0.24%)  0/402 (0.00%) 
Headache † 1  1/421 (0.24%)  0/402 (0.00%) 
Hepatic encephalopathy † 1  1/421 (0.24%)  0/402 (0.00%) 
Ischaemic cerebral infarction † 1  1/421 (0.24%)  0/402 (0.00%) 
Neurotoxicity † 1  1/421 (0.24%)  0/402 (0.00%) 
Syncope † 1  1/421 (0.24%)  2/402 (0.50%) 
Ataxia † 1  0/421 (0.00%)  1/402 (0.25%) 
Cognitive disorder † 1  0/421 (0.00%)  1/402 (0.25%) 
Depressed level of consciousness † 1  0/421 (0.00%)  1/402 (0.25%) 
Hemiparesis † 1  0/421 (0.00%)  1/402 (0.25%) 
Hypoglycaemic coma † 1  0/421 (0.00%)  1/402 (0.25%) 
Lethargy † 1  0/421 (0.00%)  1/402 (0.25%) 
Optic neuritis † 1  0/421 (0.00%)  1/402 (0.25%) 
Presyncope † 1  0/421 (0.00%)  1/402 (0.25%) 
Transient ischaemic attack † 1  0/421 (0.00%)  1/402 (0.25%) 
Psychiatric disorders     
Mental status changes † 1  2/421 (0.48%)  2/402 (0.50%) 
Confusional state † 1  1/421 (0.24%)  0/402 (0.00%) 
Depression † 1  1/421 (0.24%)  0/402 (0.00%) 
Hallucination † 1  1/421 (0.24%)  0/402 (0.00%) 
Suicidal ideation † 1  1/421 (0.24%)  0/402 (0.00%) 
Anxiety † 1  0/421 (0.00%)  2/402 (0.50%) 
Biopolar I disorder † 1  0/421 (0.00%)  1/402 (0.25%) 
Delirium † 1  0/421 (0.00%)  1/402 (0.25%) 
Renal and urinary disorders     
Renal Failure † 1  2/421 (0.48%)  3/402 (0.75%) 
Renal failure acute † 1  2/421 (0.48%)  4/402 (1.00%) 
Renal colic † 1  1/421 (0.24%)  0/402 (0.00%) 
Ureteric obstruction † 1  1/421 (0.24%)  0/402 (0.00%) 
Haematuria † 1  0/421 (0.00%)  1/402 (0.25%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism † 1  13/421 (3.09%)  20/402 (4.98%) 
Pleural effusion † 1  7/421 (1.66%)  5/402 (1.24%) 
Dyspnoea † 1  5/421 (1.19%)  2/402 (0.50%) 
Interstitial lung disease † 1  4/421 (0.95%)  2/402 (0.50%) 
Pneumonitis † 1  4/421 (0.95%)  1/402 (0.25%) 
Acute respiratory distress syndrome † 1  1/421 (0.24%)  0/402 (0.00%) 
Diffuse alveolar damage † 1  1/421 (0.24%)  0/402 (0.00%) 
Epistaxis † 1  1/421 (0.24%)  0/402 (0.00%) 
Pulmonary alveolar haemorrhage † 1  1/421 (0.24%)  0/402 (0.00%) 
Acute respiratory failure † 1  0/421 (0.00%)  1/402 (0.25%) 
Hypoxia † 1  0/421 (0.00%)  1/402 (0.25%) 
Pneumothorax † 1  0/421 (0.00%)  1/402 (0.25%) 
Skin and subcutaneous tissue disorders     
Erythema † 1  1/421 (0.24%)  0/402 (0.00%) 
Rash maculo-papular † 1  1/421 (0.24%)  0/402 (0.00%) 
Vascular disorders     
Deep vein thrombosis † 1  9/421 (2.14%)  12/402 (2.99%) 
Capilary leak syndrome † 1  1/421 (0.24%)  0/402 (0.00%) 
Hypotension † 1  1/421 (0.24%)  1/402 (0.25%) 
Labile hypertension † 1  1/421 (0.24%)  0/402 (0.00%) 
Malignant hypertension † 1  1/421 (0.24%)  0/402 (0.00%) 
Thrombosis † 1  1/421 (0.24%)  1/402 (0.25%) 
Arterial thrombosis limb † 1  0/421 (0.00%)  2/402 (0.50%) 
Hypovolaemic shock † 1  0/421 (0.00%)  1/402 (0.25%) 
Lymphoedema † 1  0/421 (0.00%)  1/402 (0.25%) 
Orthostatic hypotension † 1  0/421 (0.00%)  1/402 (0.25%) 
Phlebitis † 1  0/421 (0.00%)  1/402 (0.25%) 
Subclavian vein thrombosis † 1  0/421 (0.00%)  1/402 (0.25%) 
Venous stenosis † 1  0/421 (0.00%)  1/402 (0.25%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   412/421 (97.86%)   392/402 (97.51%) 
Blood and lymphatic system disorders     
Anaemia † 1  175/421 (41.57%)  131/402 (32.59%) 
Neutropenia † 1  172/421 (40.86%)  122/402 (30.35%) 
Thrombocytopenia † 1  127/421 (30.17%)  115/402 (28.61%) 
Leukopenia † 1  58/421 (13.78%)  39/402 (9.70%) 
Gastrointestinal disorders     
Nausea † 1  223/421 (52.97%)  189/402 (47.01%) 
Diarrhoea † 1  182/421 (43.23%)  94/402 (23.38%) 
Vomiting † 1  145/421 (34.44%)  107/402 (26.62%) 
Constipation † 1  122/421 (28.98%)  111/402 (27.61%) 
Abdominal Pain † 1  92/421 (21.85%)  87/402 (21.64%) 
Abdominal pain upper † 1  42/421 (9.98%)  28/402 (6.97%) 
Dyspepsia † 1  34/421 (8.08%)  28/402 (6.97%) 
Stomatitis † 1  31/421 (7.36%)  14/402 (3.48%) 
Abdominal distension † 1  16/421 (3.80%)  29/402 (7.21%) 
Ascites † 1  15/421 (3.56%)  26/402 (6.47%) 
General disorders     
Fatigue † 1  247/421 (58.67%)  183/402 (45.52%) 
Oedema peripheral † 1  194/421 (46.08%)  123/402 (30.60%) 
Pyrexia † 1  160/421 (38.00%)  111/402 (27.61%) 
Asthenia † 1  77/421 (18.29%)  51/402 (12.69%) 
Chills † 1  48/421 (11.40%)  34/402 (8.46%) 
Mucosal inflammation † 1  42/421 (9.98%)  16/402 (3.98%) 
Pain † 1  24/421 (5.70%)  8/402 (1.99%) 
Infections and infestations     
Urinary tract infection † 1  37/421 (8.79%)  14/402 (3.48%) 
Oral candidiasis † 1  33/421 (7.84%)  15/402 (3.73%) 
Cellulitis † 1  25/421 (5.94%)  16/402 (3.98%) 
Investigations     
Weight decreased † 1  57/421 (13.54%)  47/402 (11.69%) 
Alanine aminotransferase increased † 1  45/421 (10.69%)  36/402 (8.96%) 
Haemoglobin decreased † 1  41/421 (9.74%)  29/402 (7.21%) 
Aspartate aminotransferase increased † 1  38/421 (9.03%)  35/402 (8.71%) 
Platelet count decreased † 1  33/421 (7.84%)  25/402 (6.22%) 
Neutrophil count decreased † 1  26/421 (6.18%)  19/402 (4.73%) 
Blood alkaline phosphatase increased † 1  21/421 (4.99%)  30/402 (7.46%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  149/421 (35.39%)  104/402 (25.87%) 
Dehydration † 1  75/421 (17.81%)  33/402 (8.21%) 
Hypokalemia † 1  50/421 (11.88%)  28/402 (6.97%) 
Hypoalbuminaemia † 1  25/421 (5.94%)  18/402 (4.48%) 
Hyperglycaemia † 1  22/421 (5.23%)  18/402 (4.48%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity † 1  48/421 (11.40%)  24/402 (5.97%) 
Arthralgia † 1  46/421 (10.93%)  13/402 (3.23%) 
Myalgia † 1  44/421 (10.45%)  15/402 (3.73%) 
Back Pain † 1  41/421 (9.74%)  40/402 (9.95%) 
Bone pain † 1  24/421 (5.70%)  8/402 (1.99%) 
Nervous system disorders     
Neuropathy peripheral † 1  116/421 (27.55%)  11/402 (2.74%) 
Peripheral sensory neuropathy † 1  107/421 (25.42%)  17/402 (4.23%) 
Dysgeusia † 1  68/421 (16.15%)  33/402 (8.21%) 
Headache † 1  60/421 (14.25%)  38/402 (9.45%) 
Dizziness † 1  47/421 (11.16%)  34/402 (8.46%) 
Psychiatric disorders     
Insomnia † 1  64/421 (15.20%)  46/402 (11.44%) 
Depression † 1  50/421 (11.88%)  24/402 (5.97%) 
Anxiety † 1  35/421 (8.31%)  43/402 (10.70%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  72/421 (17.10%)  30/402 (7.46%) 
Dyspnoea † 1  71/421 (16.86%)  61/402 (15.17%) 
Epistaxis † 1  64/421 (15.20%)  14/402 (3.48%) 
Dyspnoea exertional † 1  24/421 (5.70%)  13/402 (3.23%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  212/421 (50.36%)  21/402 (5.22%) 
Rash † 1  117/421 (27.79%)  39/402 (9.70%) 
Pruritis † 1  34/421 (8.08%)  20/402 (4.98%) 
Dry Skin † 1  24/421 (5.70%)  9/402 (2.24%) 
Erythema † 1  24/421 (5.70%)  13/402 (3.23%) 
Vascular disorders     
Hypotension † 1  38/421 (9.03%)  26/402 (6.47%) 
Deep vein thrombosis † 1  30/421 (7.13%)  22/402 (5.47%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Authorship/contents of any publication is determined by site and provides sponsor a publication prior to submission. Sponsor has 60 days to review and avoid editorial changes but may request site delete confidential data. If publication contains patentable matter, site agrees to delay publication for 60 days. If study is part of multicenter protocol, site agrees not to independently publish. If multicenter publication is not forthcoming in 18 months after study end, site may proceed accordingly.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Publications of Results:
Ramanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016 Apr;27(4):648-53. doi: 10.1093/annonc/mdw020. Epub 2016 Jan 22.
Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.
Goldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients with metastatic adenocarcinoma of the pancreas: A subset analysis from a randomised phase III trial (MPACT). Eur J Cancer. 2016 Jan;52:85-91. doi: 10.1016/j.ejca.2015.10.017. Epub 2015 Dec 1.
Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardiere C, Hammel P, Lecomte T, Dreanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepere C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.
Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2):dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.
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Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00844649    
Other Study ID Numbers: CA046
First Submitted: February 13, 2009
First Posted: February 16, 2009
Results First Submitted: October 21, 2013
Results First Posted: December 11, 2013
Last Update Posted: November 25, 2019