A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
Phase 1
Completed
- Conditions
- Ovarian NeoplasmsBRCA1 ProteinBRCA2 Protein
- Interventions
- Drug: KU-0059436 (AZD2281)(PARP inhibitor)
- Registration Number
- NCT00516373
- Lead Sponsor
- AstraZeneca
- Brief Summary
To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
- Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.
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Exclusion Criteria
- Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description KU-0059436 KU-0059436 (AZD2281)(PARP inhibitor) KU-0059436 administered orally twice daily
- Primary Outcome Measures
Name Time Method To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 assessed at each visit
- Secondary Outcome Measures
Name Time Method Objective tumour response assessed every 8 weeks
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom