A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Melanoma Neoplasms

Treatments

Drug: dacarbazine

Drug: KU-0059436 (AZD2281)(PARP inhibitor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00516802

KU36-73

D0810C00003

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have:
1. Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma with metastases.
2. 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.