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

Phase 2TerminatedNCT00929162

AstraZeneca120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

Interventions

ZD4054 ZibotentanDRUG

10 mg oral tablets once daily

PaclitaxelDRUG

175mg/m2 IV on day 1 every 3 weeks

CarboplatinDRUG

Carboplatin AUC of 5.0 IV on day 1 every 3 weeks

Placebo

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Research Site

Berlin, Germany

Research Site

Dresden, Germany

Research Site

Düsseldorf, Germany

Outcomes

Primary Outcomes

Progression Free Survival

Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.

Time frame: Patients were followed for progression up to 2 years

Secondary Outcomes

Overall Survival

Median time (in months) from randomisation until death using the Kaplan-Meier method.

Time frame: Patients were followed for survival up to 2 years

Tumour Response Rate

Objective response rate defined as participants with a complete or partial response according to RECIST

Time frame: While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)

Data from ClinicalTrials.gov

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