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

Sponsor:	Pfizer
Information provided by (Responsible Party):	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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Axitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall survival [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurs first in the intention-to-treat population as a measure of Progression Free Survival. [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Number of patients with adverse events as a measure of Safety and Tolerability of AG-013736 plus gemcitabine. [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
The proportion of patients with confirmed response according to RECIST, relative to all randomized patients who have baseline measurable disease as a measure of Objective Response Rate. [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Calculation of pharmacokinetic parameters using AG-013736 plasma concentrations as a measure of Population Pharmacokinetics. [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Health-related quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Pain as measured by Quality of Life Questionnaire Pancreatic 26 (QLQ-PAN26) [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Health status as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) [ Time Frame: 23 months ] [ Designated as safety issue: No ]

Enrollment:	630
Study Start Date:	July 2007
Study Completion Date:	November 2010
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	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.
Active Comparator: B	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

Detailed Description:

This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.

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 by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kindler HL, Ioka T, Richel DJ, Bennouna J, Létourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00471146 History of Changes
Other Study ID Numbers:	A4061028
Study First Received:	May 7, 2007
Last Updated:	December 1, 2011
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.

Additional relevant MeSH terms:

Carcinoma
Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

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 24, 2012