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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556023
• Other study ID #: A3671016
• Status: Completed
• Phase: Phase 1
• First received: November 8, 2007
• Last updated: June 5, 2012
• Start date: June 2008
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Toronto	Ontario
Italy	Research Site	Candiolo (TO)
Italy	Research Site	Roma

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities: assessed through adverse event data collected weekly		8 week intervals	Yes
Secondary	HAHA Response to CP-675,206:		12 months	Yes
Secondary	Lymphocyte Subset Analysis:		12 months	No
Secondary	Cytokine Analysis:		12 months	No
Secondary	Pharmacogenomic Analysis:		1 month	No
Secondary	Overall Survival:		12 months	No
Secondary	Pharmacokinetics of CP-675,206 and Gemcitabine:		2 months	Yes
Secondary	Best Overall Response:		3 months	No
Secondary	Duration of Tumor Response:		3 months	No
Secondary	Progression-Free Survival:		5 months	No