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Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib (INTORSECT)

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ClinicalTrials.gov Identifier: NCT00474786
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : March 7, 2013
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Carcinoma
Interventions Drug: Sorafenib
Drug: temsirolimus (Torisel)
Enrollment 512
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Temsirolimus Sorafenib
Hide Arm/Group Description Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator. Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Period Title: Overall Study
Started 259 253
Completed 0 0
Not Completed 259 253
Reason Not Completed
Not Meeting Study Criteria             0             1
Investigator Request             2             1
Death             189             170
Discontinuation of Study by Sponsor             42             59
Lost to Follow-up             4             7
Protocol Violation             2             0
Withdrawal by Subject             15             15
Other             5             0
Arm/Group Title Temsirolimus Sorafenib Total
Hide Arm/Group Description Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator. Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator. Total of all reporting groups
Overall Number of Baseline Participants 259 253 512
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 259 participants 253 participants 512 participants
59.96  (10.20) 59.74  (10.33) 59.85  (10.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 259 participants 253 participants 512 participants
Female
66
  25.5%
61
  24.1%
127
  24.8%
Male
193
  74.5%
192
  75.9%
385
  75.2%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.
Time Frame Baseline up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population (ITT): all randomized participants according to their assigned treatment, regardless of whether they were received any study drug.
Arm/Group Title Temsirolimus Sorafenib
Hide Arm/Group Description:
Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Overall Number of Participants Analyzed 259 253
Median (95% Confidence Interval)
Unit of Measure: months
4.28
(4.01 to 5.43)
3.91
(2.80 to 4.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Temsirolimus, Sorafenib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1933
Comments Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.71 to 1.07
Estimation Comments Hazard ratio less than (<) 1 means temsirolimus (TEMSR) is at lower risk.
2.Secondary Outcome
Title Progression Free Survival (PFS) by Investigator Assessment
Hide Description Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.
Time Frame Baseline up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Temsirolimus Sorafenib
Hide Arm/Group Description:
Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Overall Number of Participants Analyzed 259 253
Median (95% Confidence Interval)
Unit of Measure: months
5.43
(4.24 to 5.86)
4.14
(3.26 to 5.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Temsirolimus, Sorafenib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1888
Comments Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.70 to 1.07
Estimation Comments Hazard ratio less than (<) 1 means temsirolimus (TEMSR) is at lower risk.
3.Secondary Outcome
Title Percentage of Participants With Tumor Response
Hide Description Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Time Frame Baseline up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Temsirolimus Sorafenib
Hide Arm/Group Description:
Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Overall Number of Participants Analyzed 259 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.7
(4.8 to 11.7)
7.9
(4.9 to 11.9)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Time Frame Baseline to date of death from any cause (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Temsirolimus Sorafenib
Hide Arm/Group Description:
Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Overall Number of Participants Analyzed 259 253
Median (95% Confidence Interval)
Unit of Measure: months
12.27
(10.13 to 14.80)
16.64
(13.55 to 18.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Temsirolimus, Sorafenib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0144
Comments Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and MSKCC prognostic group.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
1.05 to 1.63
Estimation Comments Hazard ratio <1 means temsirolimus (TEMSR) is at lower risk.
5.Secondary Outcome
Title Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment
Hide Description PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.
Time Frame Weeks 12, 24, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Temsirolimus Sorafenib
Hide Arm/Group Description:
Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Overall Number of Participants Analyzed 259 253
Measure Type: Number
Unit of Measure: percentage of participants
Baseline to Week 12 31.2 36.7
Week 13 to Week 24 20.9 20.1
Week 25 to Week 36 12.3 11.2
6.Secondary Outcome
Title Duration of Response (DR)
Hide Description Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.
Time Frame Baseline up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Temsirolimus Sorafenib
Hide Arm/Group Description:
Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Overall Number of Participants Analyzed 259 253
Median (95% Confidence Interval)
Unit of Measure: months
8.26
(6.71 to 10.36)
6.96
(4.18 to 17.50)
7.Other Pre-specified Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received at least 1 dose of test article.
Arm/Group Title Temsirolimus Sorafenib
Hide Arm/Group Description:
Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
Overall Number of Participants Analyzed 249 252
Measure Type: Number
Unit of Measure: participants
Serious AE 103 86
Any AE 248 251
Time Frame 5.3 years approximately
Adverse Event Reporting Description The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Temsirolimus Sorafenib
Hide Arm/Group Description Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator. Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
All-Cause Mortality
Temsirolimus Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Temsirolimus Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   104/249 (41.77%)   87/252 (34.52%) 
Blood and lymphatic system disorders     
Anaemia * 1  5/249 (2.01%)  4/252 (1.59%) 
Febrile neutropenia * 1  1/249 (0.40%)  0/252 (0.00%) 
Lymphopenia * 1  1/249 (0.40%)  0/252 (0.00%) 
Thrombocytopenia * 1  1/249 (0.40%)  0/252 (0.00%) 
Cardiac disorders     
Acute myocardial infarction * 1  1/249 (0.40%)  0/252 (0.00%) 
Atrial fibrillation * 1  0/249 (0.00%)  3/252 (1.19%) 
Atrial flutter * 1  0/249 (0.00%)  1/252 (0.40%) 
Cardiac arrest * 1  1/249 (0.40%)  0/252 (0.00%) 
Cardiac tamponade * 1  1/249 (0.40%)  0/252 (0.00%) 
Cardio-respiratory arrest * 1  1/249 (0.40%)  1/252 (0.40%) 
Cardiopulmonary failure * 1  2/249 (0.80%)  0/252 (0.00%) 
Myocardial infarction * 1  1/249 (0.40%)  4/252 (1.59%) 
Myocardial ischaemia * 1  0/249 (0.00%)  1/252 (0.40%) 
Palpitations * 1  0/249 (0.00%)  1/252 (0.40%) 
Pericardial effusion * 1  1/249 (0.40%)  0/252 (0.00%) 
Prinzmetal angina * 1  1/249 (0.40%)  0/252 (0.00%) 
Endocrine disorders     
Hyperthyroidism * 1  0/249 (0.00%)  1/252 (0.40%) 
Toxic nodular goitre * 1  0/249 (0.00%)  1/252 (0.40%) 
Eye disorders     
Retinal artery occlusion * 1  0/249 (0.00%)  1/252 (0.40%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/249 (0.40%)  1/252 (0.40%) 
Abdominal pain * 1  7/249 (2.81%)  1/252 (0.40%) 
Ascites * 1  3/249 (1.20%)  1/252 (0.40%) 
Constipation * 1  1/249 (0.40%)  1/252 (0.40%) 
Diarrhoea * 1  3/249 (1.20%)  1/252 (0.40%) 
Duodenal perforation * 1  1/249 (0.40%)  0/252 (0.00%) 
Dysphagia * 1  0/249 (0.00%)  1/252 (0.40%) 
Gastrointestinal haemorrhage * 1  0/249 (0.00%)  1/252 (0.40%) 
Gastrointestinal obstruction * 1  2/249 (0.80%)  0/252 (0.00%) 
Hernial eventration * 1  1/249 (0.40%)  0/252 (0.00%) 
Hiatus hernia * 1  0/249 (0.00%)  1/252 (0.40%) 
Intestinal obstruction * 1  1/249 (0.40%)  0/252 (0.00%) 
Intestinal ulcer perforation * 1  1/249 (0.40%)  0/252 (0.00%) 
Large intestine perforation * 1  0/249 (0.00%)  1/252 (0.40%) 
Nausea * 1  1/249 (0.40%)  0/252 (0.00%) 
Obstruction gastric * 1  0/249 (0.00%)  1/252 (0.40%) 
Oesophageal hypomotility * 1  1/249 (0.40%)  0/252 (0.00%) 
Rectal haemorrhage * 1  1/249 (0.40%)  0/252 (0.00%) 
Salivary hypersecretion * 1  1/249 (0.40%)  0/252 (0.00%) 
Stomatitis * 1  1/249 (0.40%)  0/252 (0.00%) 
Vomiting * 1  6/249 (2.41%)  4/252 (1.59%) 
General disorders     
Asthenia * 1  3/249 (1.20%)  1/252 (0.40%) 
Chest pain * 1  1/249 (0.40%)  3/252 (1.19%) 
Fatigue * 1  2/249 (0.80%)  4/252 (1.59%) 
General physical health deterioration * 1  8/249 (3.21%)  9/252 (3.57%) 
Multi-organ failure * 1  0/249 (0.00%)  1/252 (0.40%) 
Oedema peripheral * 1  2/249 (0.80%)  0/252 (0.00%) 
Pain * 1  1/249 (0.40%)  2/252 (0.79%) 
Performance status decreased * 1  1/249 (0.40%)  0/252 (0.00%) 
Pyrexia * 1  7/249 (2.81%)  4/252 (1.59%) 
Sudden death * 1  1/249 (0.40%)  1/252 (0.40%) 
Systemic inflammatory response syndrome * 1  0/249 (0.00%)  1/252 (0.40%) 
Cholecystitis acute * 1  1/249 (0.40%)  0/252 (0.00%) 
Hepatobiliary disorders     
Bile duct stone * 1  1/249 (0.40%)  0/252 (0.00%) 
Cholecystitis * 1  1/249 (0.40%)  0/252 (0.00%) 
Cholestasis * 1  1/249 (0.40%)  0/252 (0.00%) 
Gallbladder obstruction * 1  0/249 (0.00%)  1/252 (0.40%) 
Hepatobiliary disease * 1  0/249 (0.00%)  1/252 (0.40%) 
Immune system disorders     
Anaphylactic reaction * 1  1/249 (0.40%)  0/252 (0.00%) 
Drug hypersensitivity * 1  0/249 (0.00%)  1/252 (0.40%) 
Infections and infestations     
Abdominal infection * 1  1/249 (0.40%)  0/252 (0.00%) 
Abscess intestinal * 1  0/249 (0.00%)  1/252 (0.40%) 
Anal abscess * 1  0/249 (0.00%)  1/252 (0.40%) 
Bronchitis * 1  1/249 (0.40%)  0/252 (0.00%) 
Chest wall abscess * 1  0/249 (0.00%)  1/252 (0.40%) 
Cholangitis suppurative * 1  0/249 (0.00%)  1/252 (0.40%) 
Device related infection * 1  2/249 (0.80%)  0/252 (0.00%) 
Enterococcal bacteraemia * 1  0/249 (0.00%)  1/252 (0.40%) 
Hepatitis B * 1  1/249 (0.40%)  0/252 (0.00%) 
Herpes zoster * 1  1/249 (0.40%)  0/252 (0.00%) 
Infection * 1  0/249 (0.00%)  1/252 (0.40%) 
Infectious pleural effusion * 1  0/249 (0.00%)  1/252 (0.40%) 
Lobar pneumonia * 1  1/249 (0.40%)  0/252 (0.00%) 
Lower respiratory tract infection * 1  2/249 (0.80%)  0/252 (0.00%) 
Lung infection * 1  1/249 (0.40%)  0/252 (0.00%) 
Perirectal abscess * 1  1/249 (0.40%)  0/252 (0.00%) 
Pharyngitis * 1  1/249 (0.40%)  0/252 (0.00%) 
Pneumocystis jiroveci pneumonia * 1  1/249 (0.40%)  0/252 (0.00%) 
Pneumonia * 1  7/249 (2.81%)  7/252 (2.78%) 
Pneumonia influenzal * 1  1/249 (0.40%)  0/252 (0.00%) 
Pneumonia legionella * 1  1/249 (0.40%)  0/252 (0.00%) 
Pulmonary tuberculosis * 1  0/249 (0.00%)  1/252 (0.40%) 
Respiratory tract infection * 1  1/249 (0.40%)  0/252 (0.00%) 
Sepsis * 1  2/249 (0.80%)  2/252 (0.79%) 
Septic shock * 1  1/249 (0.40%)  0/252 (0.00%) 
Subcutaneous abscess * 1  1/249 (0.40%)  0/252 (0.00%) 
Tooth abscess * 1  0/249 (0.00%)  1/252 (0.40%) 
Urosepsis * 1  0/249 (0.00%)  1/252 (0.40%) 
Wound infection * 1  0/249 (0.00%)  1/252 (0.40%) 
Injury, poisoning and procedural complications     
Compression fracture * 1  1/249 (0.40%)  0/252 (0.00%) 
Hip fracture * 1  0/249 (0.00%)  1/252 (0.40%) 
Humerus fracture * 1  0/249 (0.00%)  1/252 (0.40%) 
Infusion related reaction * 1  1/249 (0.40%)  0/252 (0.00%) 
Ligament sprain * 1  0/249 (0.00%)  1/252 (0.40%) 
Lumbar vertebral fracture * 1  1/249 (0.40%)  0/252 (0.00%) 
Overdose * 1  0/249 (0.00%)  1/252 (0.40%) 
Pelvic fracture * 1  1/249 (0.40%)  0/252 (0.00%) 
Radiation mucositis * 1  0/249 (0.00%)  1/252 (0.40%) 
Investigations     
Alanine aminotransferase increased * 1  0/249 (0.00%)  2/252 (0.79%) 
Aspartate aminotransferase increased * 1  0/249 (0.00%)  3/252 (1.19%) 
Blood potassium increased * 1  0/249 (0.00%)  1/252 (0.40%) 
Prostatic specific antigen increased * 1  0/249 (0.00%)  1/252 (0.40%) 
Weight decreased * 1  0/249 (0.00%)  1/252 (0.40%) 
Metabolism and nutrition disorders     
Cachexia * 1  1/249 (0.40%)  0/252 (0.00%) 
Decreased appetite * 1  0/249 (0.00%)  2/252 (0.79%) 
Dehydration * 1  7/249 (2.81%)  6/252 (2.38%) 
Diabetes mellitus inadequate control * 1  1/249 (0.40%)  0/252 (0.00%) 
Hypercalcaemia * 1  1/249 (0.40%)  3/252 (1.19%) 
Hypercholesterolaemia * 1  1/249 (0.40%)  0/252 (0.00%) 
Hyperglycaemia * 1  2/249 (0.80%)  1/252 (0.40%) 
Hyperkalaemia * 1  0/249 (0.00%)  1/252 (0.40%) 
Hypertriglyceridaemia * 1  1/249 (0.40%)  0/252 (0.00%) 
Hyponatraemia * 1  0/249 (0.00%)  3/252 (1.19%) 
Malnutrition * 1  0/249 (0.00%)  1/252 (0.40%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/249 (0.80%)  0/252 (0.00%) 
Back pain * 1  0/249 (0.00%)  3/252 (1.19%) 
Bone lesion * 1  1/249 (0.40%)  0/252 (0.00%) 
Bone pain * 1  1/249 (0.40%)  0/252 (0.00%) 
Costochondritis * 1  0/249 (0.00%)  1/252 (0.40%) 
Flank pain * 1  1/249 (0.40%)  0/252 (0.00%) 
Intervertebral disc protrusion * 1  0/249 (0.00%)  1/252 (0.40%) 
Musculoskeletal chest pain * 1  0/249 (0.00%)  1/252 (0.40%) 
Musculoskeletal pain * 1  1/249 (0.40%)  0/252 (0.00%) 
Neck pain * 1  0/249 (0.00%)  1/252 (0.40%) 
Osteolysis * 1  1/249 (0.40%)  1/252 (0.40%) 
Pain in extremity * 1  2/249 (0.80%)  3/252 (1.19%) 
Pathological fracture * 1  1/249 (0.40%)  0/252 (0.00%) 
Spinal disorder * 1  0/249 (0.00%)  1/252 (0.40%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant pleural effusion * 1  1/249 (0.40%)  0/252 (0.00%) 
Squamous cell carcinoma * 1  0/249 (0.00%)  2/252 (0.79%) 
Nervous system disorders     
Cerebral infarction * 1  0/249 (0.00%)  1/252 (0.40%) 
Cerebral ischaemia * 1  0/249 (0.00%)  1/252 (0.40%) 
Cerebrovascular accident * 1  2/249 (0.80%)  0/252 (0.00%) 
Cognitive disorder * 1  0/249 (0.00%)  1/252 (0.40%) 
Convulsion * 1  0/249 (0.00%)  1/252 (0.40%) 
Headache * 1  1/249 (0.40%)  1/252 (0.40%) 
Hypoaesthesia * 1  0/249 (0.00%)  1/252 (0.40%) 
Paraesthesia * 1  1/249 (0.40%)  0/252 (0.00%) 
Peripheral motor neuropathy * 1  0/249 (0.00%)  1/252 (0.40%) 
Spinal cord compression * 1  1/249 (0.40%)  2/252 (0.79%) 
Syncope * 1  0/249 (0.00%)  1/252 (0.40%) 
Unresponsive to stimuli * 1  0/249 (0.00%)  1/252 (0.40%) 
Psychiatric disorders     
Completed suicide * 1  1/249 (0.40%)  1/252 (0.40%) 
Confusional state * 1  0/249 (0.00%)  3/252 (1.19%) 
Renal and urinary disorders     
Haematuria * 1  1/249 (0.40%)  0/252 (0.00%) 
Nephrotic syndrome * 1  0/249 (0.00%)  1/252 (0.40%) 
Renal failure * 1  4/249 (1.61%)  1/252 (0.40%) 
Renal failure acute * 1  1/249 (0.40%)  1/252 (0.40%) 
Renal tubular necrosis * 1  1/249 (0.40%)  0/252 (0.00%) 
Urinary retention * 1  2/249 (0.80%)  0/252 (0.00%) 
Reproductive system and breast disorders     
Prostatic haemorrhage * 1  0/249 (0.00%)  1/252 (0.40%) 
Respiratory, thoracic and mediastinal disorders     
Asthmatic crisis * 1  0/249 (0.00%)  1/252 (0.40%) 
Dyspnoea * 1  7/249 (2.81%)  8/252 (3.17%) 
Epistaxis * 1  1/249 (0.40%)  0/252 (0.00%) 
Haemoptysis * 1  0/249 (0.00%)  1/252 (0.40%) 
Interstitial lung disease * 1  2/249 (0.80%)  0/252 (0.00%) 
Lung disorder * 1  2/249 (0.80%)  0/252 (0.00%) 
Pleural effusion * 1  7/249 (2.81%)  5/252 (1.98%) 
Pleuritic pain * 1  1/249 (0.40%)  0/252 (0.00%) 
Pneumonitis * 1  7/249 (2.81%)  0/252 (0.00%) 
Pneumothorax * 1  3/249 (1.20%)  0/252 (0.00%) 
Pulmonary embolism * 1  1/249 (0.40%)  0/252 (0.00%) 
Respiratory arrest * 1  0/249 (0.00%)  1/252 (0.40%) 
Respiratory distress * 1  1/249 (0.40%)  0/252 (0.00%) 
Respiratory failure * 1  2/249 (0.80%)  2/252 (0.79%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome * 1  0/249 (0.00%)  1/252 (0.40%) 
Rash * 1  1/249 (0.40%)  2/252 (0.79%) 
Rash papular * 1  0/249 (0.00%)  1/252 (0.40%) 
Surgical and medical procedures     
Lung operation * 1  1/249 (0.40%)  0/252 (0.00%) 
Medical device implantation * 1  1/249 (0.40%)  0/252 (0.00%) 
Vascular disorders     
Haematoma * 1  0/249 (0.00%)  1/252 (0.40%) 
Haemorrhage * 1  1/249 (0.40%)  0/252 (0.00%) 
Hypertension * 1  1/249 (0.40%)  0/252 (0.00%) 
Hypotension * 1  1/249 (0.40%)  0/252 (0.00%) 
Thrombosis * 1  1/249 (0.40%)  0/252 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Temsirolimus Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   243/249 (97.59%)   249/252 (98.81%) 
Blood and lymphatic system disorders     
Anaemia * 1  83/249 (33.33%)  34/252 (13.49%) 
Lymphopenia * 1  21/249 (8.43%)  8/252 (3.17%) 
Thrombocytopenia * 1  23/249 (9.24%)  5/252 (1.98%) 
Gastrointestinal disorders     
Diarrhoea * 1  74/249 (29.72%)  156/252 (61.90%) 
Nausea * 1  81/249 (32.53%)  71/252 (28.17%) 
Constipation * 1  57/249 (22.89%)  55/252 (21.83%) 
Vomiting * 1  53/249 (21.29%)  45/252 (17.86%) 
Abdominal pain * 1  33/249 (13.25%)  41/252 (16.27%) 
Stomatitis * 1  54/249 (21.69%)  18/252 (7.14%) 
Abdominal pain upper * 1  14/249 (5.62%)  25/252 (9.92%) 
Dyspepsia * 1  15/249 (6.02%)  18/252 (7.14%) 
Oral pain * 1  13/249 (5.22%)  5/252 (1.98%) 
General disorders     
Fatigue * 1  99/249 (39.76%)  84/252 (33.33%) 
Asthenia * 1  63/249 (25.30%)  63/252 (25.00%) 
Mucosal inflammation * 1  74/249 (29.72%)  35/252 (13.89%) 
Pyrexia * 1  53/249 (21.29%)  28/252 (11.11%) 
Oedema peripheral * 1  57/249 (22.89%)  14/252 (5.56%) 
Chest pain * 1  23/249 (9.24%)  25/252 (9.92%) 
Pain * 1  20/249 (8.03%)  16/252 (6.35%) 
Oedema * 1  17/249 (6.83%)  5/252 (1.98%) 
Chills * 1  15/249 (6.02%)  6/252 (2.38%) 
Infections and infestations     
Nasopharyngitis * 1  24/249 (9.64%)  16/252 (6.35%) 
Investigations     
Weight decreased * 1  35/249 (14.06%)  51/252 (20.24%) 
Blood creatinine increased * 1  32/249 (12.85%)  6/252 (2.38%) 
Aspartate aminotransferase increased * 1  22/249 (8.84%)  15/252 (5.95%) 
Blood alkaline phosphatase increased * 1  26/249 (10.44%)  11/252 (4.37%) 
Alanine aminotransferase increased * 1  18/249 (7.23%)  17/252 (6.75%) 
Blood lactate dehydrogenase increased * 1  16/249 (6.43%)  13/252 (5.16%) 
Haemoglobin decreased * 1  19/249 (7.63%)  9/252 (3.57%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  76/249 (30.52%)  94/252 (37.30%) 
Hypertriglyceridaemia * 1  53/249 (21.29%)  18/252 (7.14%) 
Hypercholesterolaemia * 1  51/249 (20.48%)  16/252 (6.35%) 
Hyperglycaemia * 1  45/249 (18.07%)  13/252 (5.16%) 
Hypophosphataemia * 1  28/249 (11.24%)  30/252 (11.90%) 
Hyponatraemia * 1  14/249 (5.62%)  14/252 (5.56%) 
Hypocalcaemia * 1  10/249 (4.02%)  17/252 (6.75%) 
Hyperkalaemia * 1  11/249 (4.42%)  14/252 (5.56%) 
Hypokalaemia * 1  15/249 (6.02%)  9/252 (3.57%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  50/249 (20.08%)  36/252 (14.29%) 
Arthralgia * 1  46/249 (18.47%)  29/252 (11.51%) 
Pain in extremity * 1  31/249 (12.45%)  38/252 (15.08%) 
Musculoskeletal pain * 1  24/249 (9.64%)  20/252 (7.94%) 
Muscle spasms * 1  18/249 (7.23%)  22/252 (8.73%) 
Myalgia * 1  20/249 (8.03%)  17/252 (6.75%) 
Nervous system disorders     
Headache * 1  32/249 (12.85%)  44/252 (17.46%) 
Dizziness * 1  20/249 (8.03%)  20/252 (7.94%) 
Dysgeusia * 1  22/249 (8.84%)  10/252 (3.97%) 
Paraesthesia * 1  14/249 (5.62%)  10/252 (3.97%) 
Psychiatric disorders     
Insomnia * 1  15/249 (6.02%)  16/252 (6.35%) 
Anxiety * 1  13/249 (5.22%)  7/252 (2.78%) 
Renal and urinary disorders     
Dysuria * 1  13/249 (5.22%)  7/252 (2.78%) 
Pollakiuria * 1  13/249 (5.22%)  3/252 (1.19%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  85/249 (34.14%)  57/252 (22.62%) 
Dyspnoea * 1  67/249 (26.91%)  40/252 (15.87%) 
Epistaxis * 1  51/249 (20.48%)  13/252 (5.16%) 
Dysphonia * 1  5/249 (2.01%)  38/252 (15.08%) 
Oropharyngeal pain * 1  23/249 (9.24%)  15/252 (5.95%) 
Rhinorrhoea * 1  15/249 (6.02%)  7/252 (2.78%) 
Pneumonitis * 1  19/249 (7.63%)  0/252 (0.00%) 
Productive cough * 1  14/249 (5.62%)  5/252 (1.98%) 
Skin and subcutaneous tissue disorders     
Rash * 1  104/249 (41.77%)  87/252 (34.52%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  11/249 (4.42%)  131/252 (51.98%) 
Pruritus * 1  63/249 (25.30%)  64/252 (25.40%) 
Alopecia * 1  5/249 (2.01%)  78/252 (30.95%) 
Dry skin * 1  40/249 (16.06%)  36/252 (14.29%) 
Erythema * 1  15/249 (6.02%)  29/252 (11.51%) 
Nail disorder * 1  19/249 (7.63%)  0/252 (0.00%) 
Pain of skin * 1  2/249 (0.80%)  17/252 (6.75%) 
Vascular disorders     
Hypertension * 1  8/249 (3.21%)  37/252 (14.68%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.1
[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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00474786    
Other Study ID Numbers: 3066K1-404
B1771003
First Submitted: May 15, 2007
First Posted: May 17, 2007
Results First Submitted: January 31, 2013
Results First Posted: March 7, 2013
Last Update Posted: November 21, 2013