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


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicities: assessed through adverse event data collected weekly

Outcome Time Frame:

8 week intervals

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

A3671016

NCT ID:

NCT00556023

Start Date:

June 2008

Completion Date:

August 2011

Related Keywords:

  • Pancreatic Cancer
  • interventional
  • dose-finding
  • Pancreatic Neoplasms

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