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

This study has been completed.
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00516802
First received: August 13, 2007
Last updated: May 14, 2009
Last verified: May 2009

August 13, 2007
May 14, 2009
January 2007
January 2009   (final data collection date for primary outcome measure)
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine. [ Time Frame: assessed every 3 weeks ] [ Designated as safety issue: No ]
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine.
Complete list of historical versions of study NCT00516802 on ClinicalTrials.gov Archive Site
Objective tumour response [ Time Frame: assessed every 6 weeks ] [ Designated as safety issue: No ]
Objective tumour response
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma Neoplasms
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    oral
    Other Name: Olaparib
  • Drug: dacarbazine
    intravenous injection over at least 20 minutes
    Other Name: DTIC
Experimental: 1
DTIC + KU-0059436
Interventions:
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
  • Drug: dacarbazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2009
January 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00516802
KU36-73, D0810C00003
Yes
Not Provided
AstraZeneca
KuDOS Pharmaceuticals Limited
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
AstraZeneca
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP