A Phase II Open-Label, Non-Comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasm
Female
Ovarian Neoplasm
Trial Information
A Phase II Open-Label, Non-Comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer
Inclusion Criteria:
- Advanced ovarian cancer with positive BRCA1 or BRCA2 status
- Failed at least one prior chemotherapy
- In investigators opinion, no curative standard therapy exists
- Measurable disease
Exclusion Criteria:
- Brain metastases
- Less than 28 days since last treatment used to treat the disease
- Considered a poor medical risk due to a serious uncontrolled disorder
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective tumour response rate
Outcome Time Frame:
at 4 months
Safety Issue:
No
Principal Investigator
James Carmichael, BSc MBChB MD FRCP
Investigator Role:
Study Director
Investigator Affiliation:
KuDOS Pharmaceuticals Limited
Authority:
United States: Food and Drug Administration
Study ID:
KU36-58
NCT ID:
NCT00494442
Start Date:
June 2007
Completion Date:
March 2009
Related Keywords:
- Ovarian Neoplasm
- Advanced ovarian cancer
- Poly(ADP ribose) polymerases
- KU-0059436
- AZD2281
- BRCA1 protein
- BRCA2 protein
- Neoplasms
- Ovarian Neoplasms
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Beverly, Massachusetts |
| Research Site | Albany, New York |
| Research Site | Allentown, Pennsylvania |
| Research Site | Abilene, Texas |
