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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00516802

Enrollment

Registered

2007-08-15

Start date

2007-01-31

Completion date

2009-01-31

Last updated

2009-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma Neoplasms

Keywords

Poly(ADP ribose) polymerases, dacarbazine

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.

Interventions

DRUGKU-0059436 (AZD2281)(PARP inhibitor)

oral

DRUGdacarbazine

intravenous injection over at least 20 minutes

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine.	assessed every 3 weeks

Secondary

Measure	Time frame
Objective tumour response	assessed every 6 weeks

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026