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
  Purpose

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 Intervention Phase
Melanoma Neoplasms
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Drug: dacarbazine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Objective tumour response [ Time Frame: assessed every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00516802     History of Changes
Other Study ID Numbers: KU36-73, D0810C00003
Study First Received: August 13, 2007
Last Updated: May 14, 2009
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 30, 2014