Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	Sanofi-Aventis Regeneron Pharmaceuticals
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00574275

Purpose

The main objective of the study is evaluate the effectiveness of aflibercept administered once every 2 weeks in increasing the overall survival in patients with metastatic pancreatic cancer treated with gemcitabine.

Secondary objectives include response to treatment, progression free survival, safety, documentation of potential immunogenicity of aflibercept and the pharmacokinetics of aflibercept.

Condition	Intervention	Phase
Pancreatic Neoplasm	Drug: placebo Drug: Aflibercept (AVE0005)	Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Aflibercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Overall survival (OS) [ Time Frame: Study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival (PFS) [ Time Frame: Study period ] [ Designated as safety issue: No ]
Overall Response Rate [ Time Frame: every 8 weeks until disease progression ] [ Designated as safety issue: No ]
Clinical benefit based on the measurement of tumor related symptoms [ Time Frame: every 4 weeks during treatment and 8 weeks follow-up ] [ Designated as safety issue: No ]
Overall safety in the two treatment arms [ Time Frame: Study period ] [ Designated as safety issue: Yes ]
Immunogenicity of aflibercept [ Time Frame: up to 90 days post last dose of study drug ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Arm A: Experimental	Drug: Aflibercept (AVE0005) Associated to gemcitabine
Arm B: Placebo Comparator	Drug: placebo Associated to gemcitabine

Eligibility

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

Criteria

Inclusion Criteria:

Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas
Metastatic disease
No prior chemotherapy for pancreatic disease
ECOG performance status (PS) 0, 1 or 2
Adequate renal, liver and bone marrow functions

Exclusion Criteria:

Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of randomization
Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors
Uncontrolled hypertension
Pregnancy or breastfeeding
Patient with reproductive potential (M/F) without effective method of contraception

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574275

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Show 24 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Regeneron Pharmaceuticals

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC10547, AVE0005, EudraCT 2007-003476-19
Study First Received:	December 14, 2007
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00574275
Health Authority:	United States: Food and Drug Administration; Italy: Ministry of Health; Poland: Ministry of Health

Keywords provided by Sanofi-Aventis:

metastatic pancreatic cancer
angiogenesis inhibitor
gemcitabine

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009