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

This study has been terminated.
(Primary objective of the trial was not met and so there was no benefit in collecting further information)
Sponsor:
Collaborator:
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00929162
First received: June 25, 2009
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Drug: ZD4054 Zibotentan
Drug: Paclitaxel
Drug: Carboplatin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Patients were followed for progression up to 2 years ] [ Designated as safety issue: No ]
    Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Patients were followed for survival up to 2 years ] [ Designated as safety issue: No ]
    Median time (in months) from randomisation until death using the Kaplan-Meier method.

  • 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) ] [ Designated as safety issue: No ]
    Objective response rate defined as participants with a complete or partial response according to RECIST


Enrollment: 120
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929162

Locations
Germany
Research Site
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
Italy
Research Site
Milano, MI, Italy
Research Site
Perugia, PG, Italy
Research Site
Aviano, PN, Italy
Research Site
Campobasso, Italy
Research Site
Modena, Italy
Research Site
Napoli, Italy
Research Site
Roma, Italy
Sponsors and Collaborators
AstraZeneca
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
Investigators
Study Director: Tom Morris AstraZeneca, Alderley Park
Study Chair: Ian Thomas AstraZeneca, Alderley Park
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00929162     History of Changes
Other Study ID Numbers: D4320C00036
Study First Received: June 25, 2009
Results First Received: April 26, 2012
Last Updated: August 3, 2012
Health Authority: Italy: Ethics Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
ovarian
cancer
chemotherapy
sensitive
ZD4054

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014