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

Completed · Phase 1

Conditions studied: Melanoma Neoplasms

In brief

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.

Key facts

Study ID

NCT00516802

Run by

AstraZeneca

People needed

40

Starts

2007-01-01

Expected to finish

2009-01-01

Last updated by the study team

2009-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — London, United Kingdom
• Research Site — Manchester, United Kingdom
• Research Site — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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