Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
NCT00516724 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 189
Last updated 2025-04-11
Summary
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with carboplatin and/or Paclitaxel chemotherapy.
Conditions
- Triple Negative Metastatic Breast Cancer
- Advanced Ovarian Cancer
- Carboplatin
- Paclitaxel
Interventions
- DRUG
-
KU-0059436 (AZD2281)(PARP inhibitor)
oral
- DRUG
-
intravenous injection
- DRUG
-
KU-0059436 (AZD2281)(PARP inhibitor)
Oral
- DRUG
-
Intravenous injection
- DRUG
-
KU-0059436 (AZD2281)(PARP inhibitor)
Oral
- DRUG
-
Paclitaxel + Carboplatin
Intravenous injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Jane Robertson, BSc, MBCHB, MD · AstraZeneca
-
Dr Johann de Bono, MD · Cancer Research UK, The Institute of Cancer Research, London, UK
-
Prof Jan HM Schellens · The Netherlands Cancer Institute, Amsterdam, The Netherlands
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-22
- Primary Completion
- 2013-01-04
- Completion
- 2024-04-11
Countries
- Belgium
- Netherlands
- United Kingdom
Study Locations
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