Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02879318 |
|
Recruitment Status :
Active, not recruiting
First Posted : August 25, 2016
Results First Posted : May 28, 2021
Last Update Posted : March 12, 2024
|
Sponsor:
Canadian Cancer Trials Group
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Canadian Cancer Trials Group
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Pancreatic Adenocarcinoma |
| Interventions |
Drug: Gemcitabine Drug: Nab-paclitaxel Drug: Durvalumab Drug: Tremelimumab |
| Enrollment | 180 |
Participant Flow
| Recruitment Details | From April 10, 2017 to July 28, 2018 in 25 cancer centres in Canada |
| Pre-assignment Details | There was a run-in phase of this study which accrued the first patient on August 22, 2016, which can be considered as start date of this study. Only patients recruited from April 10, 2017 to July 28, 2018 into the randomized phase II component of the study were included in the analysis. |
| Arm/Group Title | Gemcitabine Plus Nab-Paclitaxel | Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab |
|---|---|---|
 Arm/Group Description |
Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days. Gemcitabine Nab-paclitaxel |
Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days. plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity. Gemcitabine Nab-paclitaxel Durvalumab Tremelimumab |
| Period Title: Overall Study | ||
| Started | 61 | 119 |
| Completed | 61 | 119 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Gemcitabine Plus Nab-Paclitaxel | Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days. Gemcitabine Nab-paclitaxel |
Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days. plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity. Gemcitabine Nab-paclitaxel Durvalumab Tremelimumab |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 61 | 119 | 180 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Continuous
Median (Full Range) Unit of measure: Years |
||||
| Number Analyzed | 61 participants | 119 participants | 180 participants | |
|
65
(42 to 84)
|
64
(29 to 81)
|
65
(29 to 84)
|
||
|
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 61 participants | 119 participants | 180 participants | |
| Younger than 65 years |
27 44.3%
|
61 51.3%
|
88 48.9%
|
|
| 65 years or older |
34 55.7%
|
58 48.7%
|
92 51.1%
|
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 61 participants | 119 participants | 180 participants | |
| Female |
35 57.4%
|
52 43.7%
|
87 48.3%
|
|
| Male |
26 42.6%
|
67 56.3%
|
93 51.7%
|
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 61 participants | 119 participants | 180 participants | |
| American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Asian |
6 9.8%
|
10 8.4%
|
16 8.9%
|
|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Black or African American |
0 0.0%
|
2 1.7%
|
2 1.1%
|
|
| White |
55 90.2%
|
105 88.2%
|
160 88.9%
|
|
| More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Unknown or Not Reported |
0 0.0%
|
2 1.7%
|
2 1.1%
|
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
| Canada | Number Analyzed | 61 participants | 119 participants | 180 participants |
| 61 | 119 | 180 | ||
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 61 participants | 119 participants | 180 participants | |
| 0 |
14 23.0%
|
27 22.7%
|
41 22.8%
|
|
| 1 |
47 77.0%
|
92 77.3%
|
139 77.2%
|
|
|
[1]
Measure Description:
0: Fully active, able to carry on all pre-disease performance without restriction
|
||||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Chris O'Callaghan |
| Organization: | Canadian Cancer Trials Group |
| Phone: | 6135336430 |
| EMail: | cocallaghan@ctg.queensu.ca |
| Responsible Party: | Canadian Cancer Trials Group |
| ClinicalTrials.gov Identifier: | NCT02879318 |
| Other Study ID Numbers: |
PA7 |
| First Submitted: | August 22, 2016 |
| First Posted: | August 25, 2016 |
| Results First Submitted: | May 5, 2021 |
| Results First Posted: | May 28, 2021 |
| Last Update Posted: | March 12, 2024 |