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

NCT00556023 | Completed Phase 1

• 1 other identifier: A3671016
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 5

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.

Conditions

Pancreatic Cancer

Keywords

interventional; dose-finding

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities: assessed through adverse event data collected weekly

  8 week intervals

Secondary Outcomes (9)

• HAHA Response to CP-675,206:

  12 months

• Lymphocyte Subset Analysis:

  12 months

• Cytokine Analysis:

  12 months

• Pharmacogenomic Analysis:

  1 month

• Overall Survival:

  12 months

Study Arms (1)

CP-675,206 and gemcitabine

EXPERIMENTAL

Drug: CP-675,206 and gemcitabine

Interventions

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.

CP-675,206 and gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Research Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Research Site

Toronto, Ontario, M5G 2M9, Canada

Location

Research Site

Montreal, Quebec, H3T 1E2, Canada

Location

Research Site

Candiolo (TO), 10060, Italy

Location

Research Site

Roma, 00168, Italy

Location

Related Publications (1)

• Aglietta M, Barone C, Sawyer MB, Moore MJ, Miller WH Jr, Bagala C, Colombi F, Cagnazzo C, Gioeni L, Wang E, Huang B, Fly KD, Leone F. A phase I dose escalation trial of tremelimumab (CP-675,206) in combination with gemcitabine in chemotherapy-naive patients with metastatic pancreatic cancer. Ann Oncol. 2014 Sep;25(9):1750-1755. doi: 10.1093/annonc/mdu205. Epub 2014 Jun 6.

  PMID: 24907635 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

tremelimumab; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 9, 2007
• Study Start: June 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

CA (3); IT (2)