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

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: CP-675,206 and gemcitabine

• Registration Number: NCT00556023
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-08
• Study First Submitted QC: 2007-11-08
• Study First Posted: 2007-11-09
• Study Start: 2008-06
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CP-675,206 and gemcitabine	CP-675,206 and gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities: assessed through adverse event data collected weekly	8 week intervals

Secondary Outcome Measures

Name	Time	Method
Pharmacogenomic Analysis:	1 month
Overall Survival:	12 months
Cytokine Analysis:	12 months
HAHA Response to CP-675,206:	12 months
Lymphocyte Subset Analysis:	12 months
Pharmacokinetics of CP-675,206 and Gemcitabine:	2 months
Best Overall Response:	3 months
Duration of Tumor Response:	3 months
Progression-Free Survival:	5 months

Trial Locations

Locations (1)

Research Site; 🇮🇹 Roma, Italy