Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan
Phase 1
Completed
- Conditions
- Malignant Solid Tumors
- Interventions
- Drug: KU-0059436 (AZD2281)(PARP inhibitor)
- Registration Number
- NCT00516438
- 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 topotecan chemotherapy in patients with advanced solid tumours
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists;
- Evaluable disease
- Adequate bone marrow, hepatic and renal function
Exclusion Criteria
- Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study
- Heavily pre treated patient > 2 previous chemotherapy regimens for metastatic disease
- Co-existing active infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 KU-0059436 (AZD2281)(PARP inhibitor) Topotecan + KU-0059436 1 Topotecan Topotecan + KU-0059436
- Primary Outcome Measures
Name Time Method To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan 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
🇬🇧Manchester, United Kingdom