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

August 3, 2012 updated by: AstraZeneca

A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 (Zibotentan) Plus Carboplatin and Paclitaxel or Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Dusseldorf, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Karlsruhe, Germany
        • Research Site
      • Kassel, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Lich, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
      • Wiesbaden, Germany
        • Research Site
  • Italy
      • Campobasso, Italy
        • Research Site
      • Modena, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Roma, Italy
        • Research Site
    • MI
      • Milano, MI, Italy
        • Research Site
    • PG
      • Perugia, PG, Italy
        • Research Site
    • PN
      • Aviano, PN, Italy
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZD4054 + paclitaxel + carboplatin
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
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
Placebo Comparator: Placebo + paclitaxel + carboplatin
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Patients were followed for progression up to 2 years
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
Patients were followed for progression up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Patients were followed for survival up to 2 years
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Patients were followed for survival up to 2 years
Tumour Response Rate
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)
Objective response rate defined as participants with a complete or partial response according to RECIST
While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI

Investigators

  • Study Director: Tom Morris, AstraZeneca, Alderley Park
  • Study Chair: Ian Thomas, AstraZeneca, Alderley Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 25, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (Estimate)

June 26, 2009

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4320C00036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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