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

NCT00536939 | Terminated Phase 2 Results DMC

• 2 other identifiers: 11396H6Q-MC-S038
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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.

  Baseline to measured PD (up to 15 days)

Secondary Outcomes (2)

• Overall Response Rate (ORR)

  Baseline to measured Progressive disease (up to 15 days)

• Number of Participants With Adverse Events (AEs) or Any Serious AEs (SAEs)

  Baseline to study completion (Day 15) plus 30-day safety follow-up

Study Arms (2)

Enzastaurin + Bevacizumab + Paclitaxel

EXPERIMENTAL

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; Drug: Bevacizumab; Drug: Paclitaxel

Bevacizumab + Paclitaxel + Placebo

PLACEBO COMPARATOR

Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.

Drug: Bevacizumab; Drug: Paclitaxel; Drug: Placebo

Interventions

Enzastaurin DRUG

1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression

Also known as: LY317615

Enzastaurin + Bevacizumab + Paclitaxel

Bevacizumab DRUG

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

Bevacizumab + Paclitaxel + Placebo; Enzastaurin + Bevacizumab + Paclitaxel

Paclitaxel DRUG

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

Bevacizumab + Paclitaxel + Placebo; Enzastaurin + Bevacizumab + Paclitaxel

Placebo DRUG

Oral, daily, until disease progression

Bevacizumab + Paclitaxel + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Genentech, Inc.: collaborator

Study Sites (7)

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, 19713, United States

Location

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, 61401, United States

Location

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, 46815, United States

Location

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, 46526, United States

Location

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, 46202, United States

Location

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, 47905, United States

Location

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, 68114, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Breast Neoplasms

Interventions

enzastaurin; Bevacizumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

The study was terminated early due to slow enrollment and competing studies.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 28, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-09

Locations

US (7)