Back to resultsA Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CP-675,206 and gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring interventional, dose-finding
Eligibility Criteria
Inclusion Criteria:
- Patients with metastatic pancreatic cancer
- Patient must have adequate bone marrow, liver and kidney function
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Chemotherapy naive
- Inoperable pancreatic cancer
Exclusion Criteria:
- Patient must not have received prior systemic therapy for pancreatic cancer
- Patient must not have previously received anti-CTLA4 therapy
- History of chronic inflammatory or autoimmune disease
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CP-675,206 and gemcitabine
Arm Description
Outcomes
Primary Outcome Measures
Dose Limiting Toxicities: assessed through adverse event data collected weekly
Secondary Outcome Measures
HAHA Response to CP-675,206:
Lymphocyte Subset Analysis:
Cytokine Analysis:
Pharmacogenomic Analysis:
Overall Survival:
Pharmacokinetics of CP-675,206 and Gemcitabine:
Best Overall Response:
Duration of Tumor Response:
Progression-Free Survival:
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00556023
Brief Title
A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer
Official Title
A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and tolerability of different doses of CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206 that is well tolerated when given in combination with gemcitabine to patients with advanced pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
interventional, dose-finding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CP-675,206 and gemcitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CP-675,206 and gemcitabine
Intervention Description
Escalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first.
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities: assessed through adverse event data collected weekly
Time Frame
8 week intervals
Secondary Outcome Measure Information:
Title
HAHA Response to CP-675,206:
Time Frame
12 months
Title
Lymphocyte Subset Analysis:
Time Frame
12 months
Title
Cytokine Analysis:
Time Frame
12 months
Title
Pharmacogenomic Analysis:
Time Frame
1 month
Title
Overall Survival:
Time Frame
12 months
Title
Pharmacokinetics of CP-675,206 and Gemcitabine:
Time Frame
2 months
Title
Best Overall Response:
Time Frame
3 months
Title
Duration of Tumor Response:
Time Frame
3 months
Title
Progression-Free Survival:
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with metastatic pancreatic cancer
Patient must have adequate bone marrow, liver and kidney function
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
Chemotherapy naive
Inoperable pancreatic cancer
Exclusion Criteria:
Patient must not have received prior systemic therapy for pancreatic cancer
Patient must not have previously received anti-CTLA4 therapy
History of chronic inflammatory or autoimmune disease
Facility Information:
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Research Site
City
Candiolo (TO)
ZIP/Postal Code
10060
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24907635
Citation
Aglietta M, Barone C, Sawyer MB, Moore MJ, Miller WH Jr, Bagala C, Colombi F, Cagnazzo C, Gioeni L, Wang E, Huang B, Fly KD, Leone F. A phase I dose escalation trial of tremelimumab (CP-675,206) in combination with gemcitabine in chemotherapy-naive patients with metastatic pancreatic cancer. Ann Oncol. 2014 Sep;25(9):1750-1755. doi: 10.1093/annonc/mdu205. Epub 2014 Jun 6.
Results Reference
derived
Learn more about this trial
A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer
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