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

Sponsor
AstraZeneca
Study ID
NCT00929162
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZD4054 Zibotentan — DRUG
    10 mg oral tablets once daily
  • Paclitaxel — DRUG
    175mg/m2 IV on day 1 every 3 weeks
  • Carboplatin — DRUG
    Carboplatin AUC of 5.0 IV on day 1 every 3 weeks
  • Placebo — DRUG
    matching placebo for ZD4054 10 mg

Study Details

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.

Key Dates

Start date
Jun 30, 2009
Status verified
Aug 2012
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ZD4054 + paclitaxel + carboplatin
    ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
  • Placebo Comparator: Placebo + paclitaxel + carboplatin
    Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks

Primary Outcome Measure

Progression Free Survival [ Time Frame: Patients were followed for progression up to 2 years ]