Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Genentech
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00536939

Purpose

The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in patients who are diagnosed with locally recurrent or metastatic breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: enzastaurin Drug: bevacizumab Drug: paclitaxel Drug: placebo	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Enzastaurin Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Phase 2 Trial of Paclitaxel Plus Bevacizumab and Enzastaurin Versus Paclitaxel Plus Bevacizumab and Placebo for Locally Recurrent or Metastatic Breast Cancer

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment:	2
Study Start Date:	November 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: enzastaurin 1125 mg loading dose then 500 mg, oral daily, until progressive disease Drug: bevacizumab 10 mg/kg, IV, Day 1 and 15 every 28 days, until disease progression Drug: paclitaxel 90 mg/m2, IV, Days 1 ,8, and 15 every 28 days until disease progression
B: Placebo Comparator	Drug: bevacizumab 10 mg/kg, IV, Day 1 and 15 every 28 days, until disease progression Drug: paclitaxel 90 mg/m2, IV, Days 1 ,8, and 15 every 28 days until disease progression Drug: placebo oral, daily, until disease progression

Eligibility

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

Criteria

Inclusion Criteria:

Must have signed an inform consent document
Have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
Have not received any prior chemotherapy for locally recurrent or metastatic disease
Have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
Age 18 years or older at time of informed consent

Exclusion Criteria:

Have any clinical evidence of central nervous system (CNS) metastases
Have a history of seizure
Have had a major surgical procedure within 4 weeks prior to assignment to study treatment
Have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
Have symptomatic peripheral vascular disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536939

Locations

United States, Delaware
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Newark, Delaware, United States, 19713
United States, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Galesburg, Illinois, United States, 61401
United States, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Wayne, Indiana, United States, 46815
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Goshen, Indiana, United States, 46526
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States, 46202
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lafayette, Indiana, United States, 47905
United States, Nebraska
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Omaha, Nebraska, United States, 68114

Sponsors and Collaborators

Eli Lilly and Company

Genentech

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11396, H6Q-MC-S038
Study First Received:	September 26, 2007
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00536939 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Tubulin Modulators
Breast Neoplasms
Antimitotic Agents

Bevacizumab
Angiogenesis Inhibitors
Antineoplastic Agents, Phytogenic
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Breast Neoplasms
Bevacizumab
Antimitotic Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009