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Completed

NCT Number: NCT00516802

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

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.

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Key information

Conditions

Melanoma Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have:
  • Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma with metastases.
  • 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.

Treatment and study plan

KU-0059436 (AZD2281)(PARP inhibitor)

Drug

oral

Other names: Olaparib

Dacarbazine

Drug

intravenous injection over at least 20 minutes

Other names: DTIC

Primary outcomes

  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 outcomes

  1. Objective tumour response

    Time frame: assessed every 6 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • KuDOS Pharmaceuticals Limited

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 15, 2007
Registry last updated
May 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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