A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Ovarian Neoplasms; BRCA2 Protein; BRCA1 Protein

Treatments: Drug: KU-0059436 (AZD2281)(PARP inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00516373

D0810C00002

KU36-92

2005-001435-29 (EudraCT Number)

Details and patient eligibility

About

To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients

Enrollment: 98 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion criteria

• Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

KU-0059436

Experimental group

Description:

KU-0059436 administered orally twice daily

Treatment:

Drug: KU-0059436 (AZD2281)(PARP inhibitor)