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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
H6Q-MC-S035
Secondary ID [2] 0 0
10536
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Randomization to measured progressive disease or death up to 14 months
Secondary outcome [1] 0 0
Expression of Tumor Markers in Tissue Samples (Tumor Markers and Genes Evaluation)
Timepoint [1] 0 0
Randomization, Cycle 2, end of study
Secondary outcome [2] 0 0
Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State
Timepoint [2] 0 0
From pre-dose to 24 hours post-dose on Day 1 of Cycle 2
Secondary outcome [3] 0 0
Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine
Timepoint [3] 0 0
Pre-dose to 6 hours post-dose on Day 1 of Cycle 2
Secondary outcome [4] 0 0
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine
Timepoint [4] 0 0
From pre-dose to 6 hours post-dose on Day 1 of Cycle 2
Secondary outcome [5] 0 0
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Timepoint [5] 0 0
Randomization to last visit (up to 9.66 months)
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Randomization to last visit (up to 9.66 months)
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Randomization to date of death from any cause up to 20.83 months
Secondary outcome [8] 0 0
Pharmacology Toxicity and Adverse Events (AEs)
Timepoint [8] 0 0
Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up]

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment hospital [4] 0 0
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
Recruitment hospital [5] 0 0
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
Recruitment hospital [6] 0 0
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
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2229 - Caringbah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Resistencia
Country [3] 0 0
Argentina
State/province [3] 0 0
Tucumain
Country [4] 0 0
France
State/province [4] 0 0
Avignon
Country [5] 0 0
France
State/province [5] 0 0
La Roche Sur Yon
Country [6] 0 0
France
State/province [6] 0 0
Lyon
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Saint-Brieuc
Country [9] 0 0
Mexico
State/province [9] 0 0
Acapulco
Country [10] 0 0
Mexico
State/province [10] 0 0
Chihuahua
Country [11] 0 0
Mexico
State/province [11] 0 0
Cuernavaca
Country [12] 0 0
Mexico
State/province [12] 0 0
Guadalajara
Country [13] 0 0
Mexico
State/province [13] 0 0
Mexico City
Country [14] 0 0
South Africa
State/province [14] 0 0
Durban

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00437294