A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine
Phase 1
Completed
- Conditions
- Melanoma Neoplasms
- Interventions
- Drug: KU-0059436 (AZD2281)(PARP inhibitor)
- Registration Number
- NCT00516802
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a Phase I, open-label, dose-escalating, study of the safety and tolerability of KU-0059436 in combination with DTIC in the treatment of patients with advanced melanoma who have not previously received systemic cytotoxic chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
-
Patients must have:
- Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma with metastases.
- Histological or cytological confirmation of melanoma. Histological confirmation of melanoma from the primary site will suffice, unless the primary site is unknown.
Exclusion Criteria
- Previous treatment with cytotoxic chemotherapy for advanced melanoma, apart from treatment for melanoma with isolated limb perfusion.
- Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).
- Major surgery within 4 weeks of starting the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 KU-0059436 (AZD2281)(PARP inhibitor) DTIC + KU-0059436 1 dacarbazine DTIC + KU-0059436
- Primary Outcome Measures
Name Time Method To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine. assessed every 3 weeks
- Secondary Outcome Measures
Name Time Method Objective tumour response assessed every 6 weeks
Trial Locations
- Locations (1)
Research Site
🇬🇧Oxford, United Kingdom