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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00067314




Registration number
NCT00067314
Ethics application status
Date submitted
15/08/2003
Date registered
18/08/2003
Date last updated
18/01/2012

Titles & IDs
Public title
Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy
Scientific title
A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer
Secondary ID [1] 0 0
EDOABC-4439-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Time to tumor response (TAR)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Duration of response (DR)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Time to tumor progression (TTP)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Time to treatment failure (TTF)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Clinical benefit
Timepoint [6] 0 0
Secondary outcome [7] 0 0
ie, a composite profile of pain intensity
Timepoint [7] 0 0
Secondary outcome [8] 0 0
analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18]
Timepoint [8] 0 0
Secondary outcome [9] 0 0
performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2]
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC]
Timepoint [10] 0 0
Secondary outcome [11] 0 0
[Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities.
Timepoint [11] 0 0
Secondary outcome [12] 0 0
Plasma pharmacokinetic parameters
Timepoint [12] 0 0

Eligibility
Key inclusion criteria
* Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
* Must have received any chemotherapy regimen in the past
* Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
* Must have measurable (by imaging techniques) disease
* Adequate bone marrow, liver and renal function
* Must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received more than 2 prior chemotherapy regimens for metastatic disease
* Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor
* Enrolled in another clinical intervention study
* Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
* Cardiac or thrombotic event in the last 12 months
* Brain metastases

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - East Bentleigh
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussel
Country [5] 0 0
Belgium
State/province [5] 0 0
Charleroi
Country [6] 0 0
Belgium
State/province [6] 0 0
Haine St. Paul
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Wilrijk
Country [9] 0 0
France
State/province [9] 0 0
Dijon
Country [10] 0 0
France
State/province [10] 0 0
Montpellier
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
France
State/province [12] 0 0
Toulouse Cedex
Country [13] 0 0
France
State/province [13] 0 0
Vandoeuvre Les Nancy

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.
Trial website
https://clinicaltrials.gov/study/NCT00067314
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00067314