A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CP-675,206 and gemcitabine

Group Type EXPERIMENTAL

CP-675,206 and gemcitabine

Intervention Type DRUG

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.

Interventions

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CP-675,206 and gemcitabine

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No