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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

DTIC + KU-0059436

Group Type EXPERIMENTAL

KU-0059436 (AZD2281)(PARP inhibitor)

Intervention Type DRUG

oral

dacarbazine

Intervention Type DRUG

intravenous injection over at least 20 minutes

Interventions

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KU-0059436 (AZD2281)(PARP inhibitor)

oral

Intervention Type DRUG

dacarbazine

intravenous injection over at least 20 minutes

Intervention Type DRUG

Other Intervention Names

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Olaparib DTIC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No