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A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms, Ovarian Cancer

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Trial Information

A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy


Inclusion Criteria:



- Have a diagnosis of advanced ovarian cancer

- Have evidence of recurrence or disease progression at least 6 months following
treatment cessation of 1st or 2nd line platinum containing therapy

- Estimated life expectancy of more than 12 weeks

Exclusion Criteria:

- Central Nervous System (CNS) metastases

- Received more than 2 prior chemotherapy regimens for ovarian cancer treatment

- Inadequate bone marrow reserve

- Inadequate liver function, renal function or low haemoglobin

- Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable
method of contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)

Outcome Description:

Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.

Outcome Time Frame:

Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)

Safety Issue:

No

Principal Investigator

Chris Poole, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry

Authority:

Bulgaria: Bulgarian Drug Agency

Study ID:

D8180C00015

NCT ID:

NCT00610714

Start Date:

April 2008

Completion Date:

January 2012

Related Keywords:

  • Ovarian Neoplasms
  • Ovarian Cancer
  • Cancer
  • Tumour
  • Ovarian Neoplasms
  • Ovarian Cancer
  • Neoplasms
  • Ovarian Neoplasms

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