Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer
Phase 1
Completed
- Conditions
- Pancreatic Neoplasms
- Interventions
- Drug: KU-0059436 (AZD2281)(PARP inhibitor)
- Registration Number
- NCT00515866
- Lead Sponsor
- AstraZeneca
- Brief 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 gemcitabine chemotherapy for the treatment of pancreatic cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of pancreas
- Locally advanced or metastatic unresectable disease
Exclusion Criteria
- No prior anti cancer chemotherapy, radiotherapy (except palliative >4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 KU-0059436 (AZD2281)(PARP inhibitor) Gemcitabine + KU-0059436 1 Gemcitabine Gemcitabine + KU-0059436
- Primary Outcome Measures
Name Time Method To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine assessed at each visit
- Secondary Outcome Measures
Name Time Method To identify the dose-limiting toxicity of the combination therapy assessed at each visit
Trial Locations
- Locations (1)
Research Site
🇬🇧Oxford, United Kingdom