ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: ZD4054 Zibotentan; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00929162

D4320C00036

Details and patient eligibility

About

The purpose of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma
• Radiologically documented measurable disease according to RECIST criteria assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging MRI) or radiologically documented non-measurable (but evaluable) disease.
• Advanced disease not amenable to curative surgery or radiotherapy at the time of study entry with evidence of disease recurrence or progression at least 6 months following treatment cessation of first-line platinum- containing therapy

Exclusion criteria

• Clinical evidence of central nervous system (CNS) metastases
• Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum
• Tumour of borderline malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

ZD4054 + paclitaxel + carboplatin

Experimental group

Description:

ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks

Treatment:

Drug: ZD4054 Zibotentan

Drug: Paclitaxel

Drug: Carboplatin

Placebo + paclitaxel + carboplatin

Placebo Comparator group

Description:

Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Placebo