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Clinical Trials/NCT00556023
NCT00556023
Completed
Phase 1

A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer

AstraZeneca1 site in 1 country37 target enrollmentJune 2008
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ConditionsPancreatic Cancer
InterventionsCP-675,206 and gemcitabine
DrugsCP-675,206 and gemcitabine

Overview

Phase
Phase 1
Intervention
CP-675,206 and gemcitabine
Conditions
Pancreatic Cancer
Sponsor
AstraZeneca
Enrollment
37
Locations
1
Primary Endpoint
Dose Limiting Toxicities: assessed through adverse event data collected weekly
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
August 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

CP-675,206 and gemcitabine

Intervention: CP-675,206 and gemcitabine

Outcomes

Primary Outcomes

Dose Limiting Toxicities: assessed through adverse event data collected weekly

Time Frame: 8 week intervals

Secondary Outcomes

  • 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)

Study Sites (1)

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