Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer (ICEBERG 3)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasms

Treatments: Drug: AZD2281; Drug: Liposomal Doxorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628251

D0810C00012

Details and patient eligibility

About

The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.

Enrollment: 97 patients

Sex: Female

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced ovarian cancer with positive BRCA1 or BRCA2 status
• Progressive or recurrent disease after platinum-based chemotherapy
• Measurable disease by RECIST

Exclusion criteria

• Previous anthracycline treatment
• 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 3 patient groups

1

Experimental group

Description:

AZD2281 Oral 200 mg BID

Treatment:

Drug: AZD2281

Drug: AZD2281

2

Active Comparator group

Description:

Liposomal Doxorubicin

Treatment:

Drug: Liposomal Doxorubicin

3

Experimental group

Description:

AZD2281 Oral 400 mg BID

Treatment:

Drug: AZD2281

Drug: AZD2281