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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00516802
Recruitment Status : Completed
First Posted : August 15, 2007
Last Update Posted : May 15, 2009
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by:
AstraZeneca

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma Neoplasms Drug: KU-0059436 (AZD2281)(PARP inhibitor) Drug: dacarbazine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2007
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
DTIC + KU-0059436
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Name: Olaparib
Drug: dacarbazine
intravenous injection over at least 20 minutes
Other Name: DTIC



Primary Outcome Measures :
  1. To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine. [ Time Frame: assessed every 3 weeks ]

Secondary Outcome Measures :
  1. Objective tumour response [ Time Frame: assessed every 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516802


Locations
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States
United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
AstraZeneca
KuDOS Pharmaceuticals Limited
Investigators
Study Director: Prof James Carmichael, BSc MBChB MD FRCP KuDOS Pharmaceuticals Ltd
Principal Investigator: Prof Martin Gore, PhD MRCP FRCR Royal Marsden Hospital Trust, London, UK

ClinicalTrials.gov Identifier: NCT00516802     History of Changes
Other Study ID Numbers: KU36-73
D0810C00003
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009

Keywords provided by AstraZeneca:
Poly(ADP ribose) polymerases
dacarbazine

Additional relevant MeSH terms:
Poly(ADP-ribose) Polymerase Inhibitors
Olaparib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents