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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase I

Treatment

Closed

18 and over

Pharmaceutical / Industry

KU36-73
D0810C00003, NCT00516802

Trial Description

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.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

AstraZeneca Pharmaceuticals LP

Kudos Pharmaceuticals

Prof James Carmichael, BSc MBChB MD FRCP

Study Director

Prof Martin Gore, PhD MRCP FRCR

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00516802
Information obtained from ClinicalTrials.gov on September 15, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.