Trial | NCT00516802  Report issue

Title

A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine
A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 and Dacarbazine in the Treatment of Patients With Advanced Solid Tumours

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    olaparib dacarbazine ...

  • Study Participants

    40
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.
Study Started
Jan 31
2007
Primary Completion
Jan 31
2009
Study Completion
Jan 31
2009
Last Update
May 15
2009
Estimate

Drug KU-0059436 (AZD2281)(PARP inhibitor)

oral

  • Other names: Olaparib

Drug dacarbazine

intravenous injection over at least 20 minutes

  • Other names: DTIC

1 Experimental

DTIC + KU-0059436

Criteria 

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.
No Results Posted