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

NCT00929162 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-08-07

Study results available
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Summary

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.

Conditions

  • Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

Interventions

DRUG

ZD4054 Zibotentan

10 mg oral tablets once daily

DRUG

Paclitaxel

175mg/m2 IV on day 1 every 3 weeks

DRUG

Carboplatin

Carboplatin AUC of 5.0 IV on day 1 every 3 weeks

DRUG

Placebo

matching placebo for ZD4054 10 mg

Sponsors & Collaborators

  • ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Tom Morris · AstraZeneca, Alderley Park

  • Ian Thomas · AstraZeneca, Alderley Park

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Germany
  • Italy

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00929162 on ClinicalTrials.gov