AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer (OVERT-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00610714
First received: January 23, 2008
Last updated: December 14, 2012
Last verified: December 2012

January 23, 2008
December 14, 2012
April 2008
August 2009   (final data collection date for primary outcome measure)
Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) [ 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) ] [ Designated as safety issue: No ]
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.
To compare the objective tumour response rate, as evaluated according to RECIST guidelines, in patients treated with AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone [ Time Frame: Assessed after each treatment over a period of 8 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00610714 on ClinicalTrials.gov Archive Site
  • Progression-free Survival (PFS) as Evaluated by RECIST [ Time Frame: Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred) ] [ Designated as safety issue: No ]
    Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.
  • Overall Survival (Number of Deaths) [ Time Frame: Date of randomization to death due to any cause ] [ Designated as safety issue: No ]
    Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead
  • To investigate the safety and tolerability of AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone. [ Time Frame: Assessed after each treatment over a period of 8 months ] [ Designated as safety issue: No ]
  • To compare progression-free survival in patients treated with AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone. [ Time Frame: Assessed after each treatment over a period of 8 months + 1 month followup ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Ovarian Neoplasms
  • Ovarian Cancer
  • Drug: AZD0530
    oral once daily dose
  • Drug: Carboplatin
    intravenous injection
    Other Names:
    • CBDCA
    • Paraplatin®
  • Drug: Paclitaxel
    intravenous infusion
    Other Name: Taxol®
  • Active Comparator: Active Comparator
    carboplatin plus paclitaxel
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: 2
    AZD0530 in combination with carboplatin plus paclitaxel
    Interventions:
    • Drug: AZD0530
    • Drug: Carboplatin
    • Drug: Paclitaxel
Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
January 2012
August 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Bulgaria,   Canada,   Denmark,   United Kingdom,   Netherlands,   Norway,   Peru,   Portugal,   Romania,   Russian Federation,   Spain
 
NCT00610714
D8180C00015, AZD0530 Study 15
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Chris Poole, Prof Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry
Study Director: Mireille Cantarini, MD AstraZeneca
AstraZeneca
December 2012

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