AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer (OVERT-1)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasms; Ovarian Cancer

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: AZD0530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00610714

AZD0530 Study 15

D8180C00015

Details and patient eligibility

About

The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer

Enrollment: 211 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of advanced ovarian cancer
• Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy
• Estimated life expectancy of more than 12 weeks

Exclusion criteria

• Central Nervous System (CNS) metastases
• Received more than 2 prior chemotherapy regimens for ovarian cancer treatment
• Inadequate bone marrow reserve
• Inadequate liver function, renal function or low haemoglobin
• Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable method of contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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211 participants in 2 patient groups

Active Comparator

Active Comparator group

Description:

carboplatin plus paclitaxel

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

2

Experimental group

Description:

AZD0530 in combination with carboplatin plus paclitaxel

Treatment:

Drug: AZD0530

Drug: Carboplatin

Drug: Paclitaxel