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Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00536939
Recruitment Status : Terminated (Study has been terminated due to slow enrollment)
First Posted : September 28, 2007
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Enzastaurin Drug: Bevacizumab Drug: Paclitaxel Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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).

Drug: Enzastaurin
1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression
Other Name: LY317615

Drug: Bevacizumab
10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression

Drug: Paclitaxel
90 milligrams per square meter (mg/m^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression

Placebo Comparator: Bevacizumab + Paclitaxel + Placebo
Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.
Drug: Bevacizumab
10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression

Drug: Paclitaxel
90 milligrams per square meter (mg/m^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression

Drug: Placebo
Oral, daily, until disease progression




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to measured PD (up to 15 days) ]
    PFS was defined as the time from the date of study enrollment to the first date of objectively determined progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). PD is ≥20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died and who did not have PD, PFS was censored at the date of the last progression-free assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. No participant completed a full cycle of therapy and thus no formal analysis was performed.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Baseline to measured Progressive disease (up to 15 days) ]
    ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR), assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). CR was defined as the disappearance of all tumor lesions; PR was defined as either ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case of PR, no new lesions should have appeared. The percentage of participants with ORR was calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100. No participant completed a full cycle of therapy and thus no formal analysis was performed.

  2. Number of Participants With Adverse Events (AEs) or Any Serious AEs (SAEs) [ Time Frame: Baseline to study completion (Day 15) plus 30-day safety follow-up ]
    A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536939


Locations
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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, Inc.
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00536939    
Other Study ID Numbers: 11396
H6Q-MC-S038 ( Other Identifier: Eli Lilly and Company )
First Posted: September 28, 2007    Key Record Dates
Results First Posted: September 24, 2020
Last Update Posted: September 24, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors