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.
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).
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the synthetic lethality of KU-0059436 in BRCA1/2-mutated ovarian cancer?
How does the efficacy of KU-0059436 compare to olaparib in BRCA1/2-mutated advanced ovarian neoplasms?
What biomarkers beyond BRCA1/2 mutations predict response to KU-0059436 in ovarian cancer patients?
What are the key adverse events observed in NCT00516373 Phase I trials and their management strategies in BRCA1/2-mutated tumours?
What combination therapies with KU-0059436 have shown enhanced efficacy in BRCA1/2-associated solid tumours compared to monotherapy?
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom