Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer
NCT ID: NCT00536939
Last Updated: 2020-09-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2007-11-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Enzastaurin + Bevacizumab + Paclitaxel
Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression.
Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A).
Enzastaurin
1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression
Bevacizumab
10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression
Paclitaxel
90 milligrams per square meter (mg/m\^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression
Bevacizumab + Paclitaxel + Placebo
Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.
Bevacizumab
10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression
Paclitaxel
90 milligrams per square meter (mg/m\^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression
Placebo
Oral, daily, until disease progression
Interventions
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Enzastaurin
1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression
Bevacizumab
10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression
Paclitaxel
90 milligrams per square meter (mg/m\^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression
Placebo
Oral, daily, until disease progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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
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
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
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
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
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
Countries
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Other Identifiers
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H6Q-MC-S038
Identifier Type: OTHER
Identifier Source: secondary_id
11396
Identifier Type: -
Identifier Source: org_study_id
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