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

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: CP-675,206 and gemcitabine	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Dose Limiting Toxicities: assessed through adverse event data collected weekly [ Time Frame: 8 week intervals ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HAHA Response to CP-675,206: [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Lymphocyte Subset Analysis: [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cytokine Analysis: [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Pharmacogenomic Analysis: [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Overall Survival: [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Pharmacokinetics of CP-675,206 and Gemcitabine: [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Best Overall Response: [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Duration of Tumor Response: [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Progression-Free Survival: [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment:	37
Study Start Date:	June 2008
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CP-675,206 and gemcitabine	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.

Arms

Assigned Interventions

Experimental: CP-675,206 and gemcitabine

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556023

Locations

Canada, Alberta
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3T 1E2
Italy
Research Site
Candiolo (TO), Italy, 10060
Research Site
Roma, Italy, 00168

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00556023 History of Changes
Other Study ID Numbers:	A3671016
Study First Received:	November 8, 2007
Last Updated:	June 5, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

interventional
dose-finding

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 19, 2013