Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
Study Details
Study Description
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 carboplatin and/or Paclitaxel chemotherapy.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Carboplatin + KU-0059436 |
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Names:
Drug: Carboplatin
intravenous injection
Other Names:
|
Experimental: 2. Paclitaxel + KU-0059436 |
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Oral
Other Names:
Drug: Paclitaxel
Intravenous injection
|
Experimental: 3. Paclitaxel, Carboplatin + KU-0059436 |
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Oral
Other Names:
Drug: Paclitaxel + Carboplatin
Intravenous injection
|
Outcome Measures
Primary Outcome Measures
- To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin [assessed at each visit]
Secondary Outcome Measures
- To identify the dose limiting toxicity of the combination therapy [assessed at each visit]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female patients with a histologically or cytologically diagnosed malignant solid tumour
-
Adequate bone marrow, hepatic and renal function
-
Performance status of no more than 2 ( ECOG scale).
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 and must have recovered from effects of the major surgery
-
More than two previous courses of platinum-containing chemotherapy
-
Heavily pre-treated patients(> 2 courses of previous chemotherapy and/or extensive irradiation leading to bone marrow deficiency) will be excluded from the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Site | Brussels | Belgium | 1090 | |
2 | Research Site | Amsterdam | Netherlands | 1066 EC | |
3 | Research Site | Rotterdam | Netherlands | 3015 | |
4 | Research Site | London | United Kingdom | SM2 5NG |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Jane Robertson, BSc, MBCHB, MD, AstraZeneca
- Principal Investigator: Dr Johann de Bono, MD, Cancer Research UK, The Institute of Cancer Research, London, UK
- Principal Investigator: Prof Jan HM Schellens, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- KU36-96
- D0810C00004