- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00437294
Enzastaurin in Combination of Capecitabine to Treat Breast Cancer
July 20, 2020 updated by: Eli Lilly and Company
A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane
The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1430
- 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.
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Resistencia, Argentina, 3500
- 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.
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Tucumain, Argentina, 4000
- 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.
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Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2605
- 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.
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New South Wales
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Caringbah, New South Wales, Australia, 2229
- 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.
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Wollongong, New South Wales, Australia, 2500
- 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.
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Victoria
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Frankston, Victoria, Australia, 3199
- 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.
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- 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.
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Subiaco, Western Australia, Australia, 6008
- 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.
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Avignon, France, 84082
- 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.
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La Roche Sur Yon, France, 85925
- 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.
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Lyon, France, 69373
- 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.
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Paris, France, 75651
- 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.
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Saint-Brieuc, France, 22015
- 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.
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Acapulco, Mexico, 39670
- 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.
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Chihuahua, Mexico, 31238
- 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.
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Cuernavaca, Mexico, 62290
- 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.
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Guadalajara, Mexico, 44670
- 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.
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Mexico City, Mexico, 07300
- 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.
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Durban, South Africa, 4091
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Have been diagnosed with metastatic or recurrent breast cancer.
- Have been previously treated with both an anthracycline and a taxane.
- Have not received more than two prior chemotherapy treatment programs.
- Have stopped any antitumoral hormonal treatment before you enroll in this study.
- Have a negative pregnancy blood test if menstruating or capable of becoming pregnant. You must use an approved birth control method during the study and for 3 months after stopping study treatment.
Exclusion Criteria:
- Cannot follow the study procedures (for example, you cannot swallow tablets).
- Are receiving another treatment for your cancer.
- Have received another experimental drug in the last 4 weeks.
- Have had serious heart disease within last 6 months.
- Are pregnant or breast-feeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Capecitabine + Enzastaurin
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1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease
Other Names:
1250 mg/m^2, BID, days 1-14 of each 21-day cycle until progressive disease
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Placebo Comparator: Capecitabine + Placebo
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1250 mg/m^2, BID, days 1-14 of each 21-day cycle until progressive disease
oral, daily, 21-day cycles until progressive disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression Free Survival (PFS)
Time Frame: Randomization to measured progressive disease or death up to 14 months
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PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause.
For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment.
For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.
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Randomization to measured progressive disease or death up to 14 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Expression of Tumor Markers in Tissue Samples (Tumor Markers and Genes Evaluation)
Time Frame: Randomization, Cycle 2, end of study
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Protein expression was planned to be measured using an Immunohistochemistry (IHC) assay to determine membrane and cytoplasmic phosphorylated glycogen synthase kinase 3 beta (pGSK3B), nuclear phosphorylated adenosine 3'5'-cyclic monophosphate (cAMP) response-element binding protein (pCREB), cytoplasmic pCREB, protein kinase C beta 2 (PKCB2), cytoplasmic phospho S6 (pS6), and cytoplasmic phosphatase and tensin homolog (PTEN) IHC H-scores.
Tumor tissue samples were to be scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H- scores calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+) .
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Randomization, Cycle 2, end of study
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Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State
Time Frame: From pre-dose to 24 hours post-dose on Day 1 of Cycle 2
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Area Under the Concentration versus time curve during 1 dosing interval at steady state (AUCτ,ss) for Cycle 2 Day 1 for Enzastaurin, its metabolite LY326020 and total analytes (enzastaurin + LY326020).
AUCτ,ss was calculated using concentration versus time data by post hoc estimation of enzastaurin, its metabolite LY326020, and total analytes (enzastaurin + LY326020).
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From pre-dose to 24 hours post-dose on Day 1 of Cycle 2
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Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine
Time Frame: Pre-dose to 6 hours post-dose on Day 1 of Cycle 2
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AUC0-tlast for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Cycle 2, Day 1.
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Pre-dose to 6 hours post-dose on Day 1 of Cycle 2
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Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine
Time Frame: From pre-dose to 6 hours post-dose on Day 1 of Cycle 2
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Cmax for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and its metabolites 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Day 1 of Cycle 2.
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From pre-dose to 6 hours post-dose on Day 1 of Cycle 2
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Time Frame: Randomization to last visit (up to 9.66 months)
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Response rate was defined as percent of participants with objective response [CR or PR] over randomized and treated participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) Guidelines.
CR was defined as the disappearance of all tumor lesions.
PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of one or more non-target lesions.
No new lesions may have appeared.
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Randomization to last visit (up to 9.66 months)
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Duration of Response (DOR)
Time Frame: Randomization to last visit (up to 9.66 months)
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The DOR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause.
According to the Response Evaluation Criteria in Solid Tumors (RECIST V1.0) criteria, CR was the disappearance of all tumor lesions.
PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions, with occurrence of no new lesions.
For participants not known to have died as of the data cut-off date and who did not have progressive disease, DOR was censored at the date of last visit with adequate assessment.
For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, DOR was censored at the date of last visit with adequate assessment.
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Randomization to last visit (up to 9.66 months)
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Overall Survival (OS)
Time Frame: Randomization to date of death from any cause up to 20.83 months
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OS was defined as the time in months from the date of study enrollment to the date of death from any cause.
For participants not known to have died as of the cut-off date, OS was censored at the last contact date.
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Randomization to date of death from any cause up to 20.83 months
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Pharmacology Toxicity and Adverse Events (AEs)
Time Frame: Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up]
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Data presented are the number of participants who experienced serious AEs, AEs, death due to progressive disease (PD), death due to AEs while on treatment and death during the 30-day post-treatment.
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
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Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up]
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
February 16, 2007
First Submitted That Met QC Criteria
February 16, 2007
First Posted (Estimate)
February 19, 2007
Study Record Updates
Last Update Posted (Actual)
August 10, 2020
Last Update Submitted That Met QC Criteria
July 20, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10536
- H6Q-MC-S035 (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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