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

NCT00516802 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-05-15

No results posted yet for this study

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.

Conditions

  • Melanoma Neoplasms

Interventions

DRUG

KU-0059436 (AZD2281)(PARP inhibitor)

oral

DRUG

dacarbazine

intravenous injection over at least 20 minutes

Sponsors & Collaborators

  • KuDOS Pharmaceuticals Limited

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Prof James Carmichael, BSc MBChB MD FRCP · KuDOS Pharmaceuticals Ltd

  • Prof Martin Gore, PhD MRCP FRCR · Royal Marsden Hospital Trust, London, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00516802 on ClinicalTrials.gov