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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00437294
Registration number
NCT00437294
Ethics application status
Date submitted
16/02/2007
Date registered
19/02/2007
Date last updated
10/08/2020
Titles & IDs
Public title
Enzastaurin in Combination of Capecitabine to Treat Breast Cancer
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Scientific title
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
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Secondary ID [1]
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H6Q-MC-S035
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Secondary ID [2]
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10536
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - enzastaurin
Treatment: Drugs - placebo
Treatment: Drugs - capecitabine
Experimental: Capecitabine + Enzastaurin -
Placebo Comparator: Capecitabine + Placebo -
Treatment: Drugs: enzastaurin
1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease
Treatment: Drugs: placebo
oral, daily, 21-day cycles until progressive disease
Treatment: Drugs: capecitabine
1250 mg/m^2, BID, days 1-14 of each 21-day cycle until progressive disease
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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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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Timepoint [1]
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Randomization to measured progressive disease or death up to 14 months
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Secondary outcome [1]
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Expression of Tumor Markers in Tissue Samples (Tumor Markers and Genes Evaluation)
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Assessment method [1]
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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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Timepoint [1]
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Randomization, Cycle 2, end of study
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Secondary outcome [2]
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Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State
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Assessment method [2]
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Area Under the Concentration versus time curve during 1 dosing interval at steady state (AUCt,ss) for Cycle 2 Day 1 for Enzastaurin, its metabolite LY326020 and total analytes (enzastaurin + LY326020). AUCt,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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Timepoint [2]
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From pre-dose to 24 hours post-dose on Day 1 of Cycle 2
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Secondary outcome [3]
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Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine
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Assessment method [3]
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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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Timepoint [3]
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Pre-dose to 6 hours post-dose on Day 1 of Cycle 2
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Secondary outcome [4]
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Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine
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Assessment method [4]
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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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Timepoint [4]
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From pre-dose to 6 hours post-dose on Day 1 of Cycle 2
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Secondary outcome [5]
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
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Assessment method [5]
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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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Timepoint [5]
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Randomization to last visit (up to 9.66 months)
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Secondary outcome [6]
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Duration of Response (DOR)
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Assessment method [6]
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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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Timepoint [6]
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Randomization to last visit (up to 9.66 months)
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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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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Timepoint [7]
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Randomization to date of death from any cause up to 20.83 months
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Secondary outcome [8]
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Pharmacology Toxicity and Adverse Events (AEs)
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Assessment method [8]
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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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Timepoint [8]
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Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up]
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2009
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Sample size
Target
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Accrual to date
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Final
86
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
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Recruitment hospital [1]
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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. - Garran
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Recruitment hospital [2]
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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. - Caringbah
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Recruitment hospital [3]
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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. - Wollongong
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Recruitment hospital [4]
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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. - Frankston
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Recruitment hospital [5]
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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. - Nedlands
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Recruitment hospital [6]
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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. - Subiaco
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2229 - Caringbah
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Recruitment postcode(s) [3]
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2500 - Wollongong
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment postcode(s) [6]
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6008 - Subiaco
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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Resistencia
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Country [3]
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Argentina
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State/province [3]
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Tucumain
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Country [4]
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France
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State/province [4]
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Avignon
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Country [5]
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France
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State/province [5]
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La Roche Sur Yon
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Country [6]
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France
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State/province [6]
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Lyon
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Country [7]
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France
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State/province [7]
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Paris
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Country [8]
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France
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State/province [8]
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Saint-Brieuc
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Country [9]
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Mexico
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State/province [9]
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Acapulco
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Country [10]
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Mexico
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State/province [10]
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Chihuahua
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Country [11]
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Mexico
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State/province [11]
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Cuernavaca
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Country [12]
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Mexico
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State/province [12]
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Guadalajara
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Country [13]
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Mexico
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State/province [13]
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Mexico City
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Country [14]
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South Africa
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State/province [14]
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Durban
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00437294
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00437294
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