Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00471146

Purpose

The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

Condition	Intervention	Phase
Carcinoma, Pancreatic Ductal	Drug: AG-013736 Drug: Gemcitabine Drug: placebo	Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall survival is the primary endpoint. A total of 596 patients and 460 events are required for a log rank test to have an overall 1 sided significance level of 0.025 and power of 0.90. [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective response rate (the proportion of patients with confirmed response according to RECIST, relative to all randomized patients who have baseline measurable disease). [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Safety and tolerability of AG-013736 plus gemcitabine. All patients who receive any study treatment will be included in the final summaries and listings of safety data. [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
Duration of response (the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first). [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Health-related quality of life, pain ratings, and health status of patients in each arm as measured by the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire Core 30 (EORTC QLQ C30) and Pancreatic 26 (PAN26), [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
BPI sf, and EQ 5D. Questionnaires will be completed prior to dosing and ideally before any clinical assessments. [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
Population pharmacokinetic analysis using AG-013736 plasma concentrations. [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Progression free survival (the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurs first). [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	596
Study Start Date:	August 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: AG-013736 oral administration, starting dose 5 mg BID every day until unacceptable toxicity or tumor progression. Drug: Gemcitabine intravenous administration at 1,000 mg/m2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
B: Active Comparator	Drug: Gemcitabine intravenous administration at 1,000 mg/m2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression. Drug: placebo placebo

Eligibility

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

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
Adequate renal, hepatic and bone marrow function.
Performance status 0 or 1.

Exclusion Criteria:

Prior treatment with any systemic chemotherapy for metastatic disease.
Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
Inability to take oral medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471146

Show 205 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061028
Study First Received:	May 7, 2007
Last Updated:	April 25, 2009
ClinicalTrials.gov Identifier:	NCT00471146 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.

Study placed in the following topic categories:

Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Carcinoma, Ductal
Carcinoma, Pancreatic Ductal

Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Carcinoma, Pancreatic Ductal
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type

Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Carcinoma, Ductal
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009