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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
History of Changes

June 25, 2009
August 3, 2012
June 2009
June 2011   (final data collection date for primary outcome measure)
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.
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 [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00929162 on ClinicalTrials.gov Archive Site
  • 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
  • To compare overall survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • To compare the objective tumour response rate, as evaluated according to RECIST criteria in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • To investigate the safety and tolerability of ZD4054 given in combination with carboplatin/paclitaxel in patients with advanced ovarian cancer [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
  • 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
  • Experimental: ZD4054 + paclitaxel + carboplatin
    ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
    Interventions:
    • Drug: ZD4054 Zibotentan
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Placebo Comparator: Placebo + paclitaxel + carboplatin
    Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy
 
NCT00929162
D4320C00036
No
AstraZeneca
AstraZeneca
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
Study Director: Tom Morris AstraZeneca, Alderley Park
Study Chair: Ian Thomas AstraZeneca, Alderley Park
AstraZeneca
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP