Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer (ICEBERG 2)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasm

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494442

KU36-58

D0810C00009

Details and patient eligibility

About

The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.

Enrollment: 58 patients

Sex: Female

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced ovarian cancer with positive BRCA1 or BRCA2 status
• Failed at least one prior chemotherapy
• In investigators opinion, no curative standard therapy exists
• Measurable disease

Exclusion criteria

• Brain metastases
• Less than 28 days since last treatment used to treat the disease
• Considered a poor medical risk due to a serious uncontrolled disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

KU-0059436 (AZD2281) 100 mg BID

Experimental group

Treatment:

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

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

KU-0059436 (AZD2281) 400 mg BID

Experimental group

Treatment:

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

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