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Completed

NCT Number: NCT00556023

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

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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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-675,206 and gemcitabine

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.

Primary outcomes

  1. Dose Limiting Toxicities: assessed through adverse event data collected weekly

    Time frame: 8 week intervals

Secondary outcomes

  1. HAHA Response to CP-675,206:

    Time frame: 12 months

  2. Lymphocyte Subset Analysis:

    Time frame: 12 months

  3. Cytokine Analysis:

    Time frame: 12 months

  4. Pharmacogenomic Analysis:

    Time frame: 1 month

  5. Overall Survival:

    Time frame: 12 months

  6. Pharmacokinetics of CP-675,206 and Gemcitabine:

    Time frame: 2 months

  7. Best Overall Response:

    Time frame: 3 months

  8. Duration of Tumor Response:

    Time frame: 3 months

  9. Progression-Free Survival:

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2007
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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