Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer (ICEBERG 3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00628251
First received: February 26, 2008
Last updated: November 5, 2014
Last verified: November 2014

February 26, 2008
November 5, 2014
July 2008
September 2009   (final data collection date for primary outcome measure)
Efficacy comparison of 400 mg bd and 200 mg bd AZD2281 v 50mg/m2 doxil every 4 weeks in BRCA1 or 2 associated advanced ovarian cancer patients by PFS (primary variable), ORR, duration of response and CA-125 levels [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
Efficacy comparison of 400 mg bd, 100 mg bd and 100 mg od AZD2281 v 50mg/m2 doxil every 4 weeks in BRCA1 or 2 associated advanced ovarian cancer patients by PFS (primary variable), ORR, duration of response and CA-125 levels (secondary variables) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00628251 on ClinicalTrials.gov Archive Site
Comparison of safety and tolerability [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
Comparison of safety and tolerability [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer
A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy

The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Neoplasms
  • Drug: AZD2281
    400mg Oral twice daily
    Other Name: Olaparib
  • Drug: Liposomal Doxorubicin
    50mg/m2 Monthly Intravenous
    Other Name: Doxil®
  • Drug: AZD2281
    200mg oral twice daily
  • Experimental: 1
    AZD2281 Oral 200 mg BID
    Intervention: Drug: AZD2281
  • Active Comparator: 2
    Liposomal Doxorubicin
    Intervention: Drug: Liposomal Doxorubicin
  • Experimental: 3
    AZD2281 Oral 400 mg BID
    Intervention: Drug: AZD2281

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
125
December 2015
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced ovarian cancer with positive BRCA1 or BRCA2 status
  • Progressive or recurrent disease after platinum-based chemotherapy
  • Measurable disease by RECIST

Exclusion Criteria:

  • Previous anthracycline treatment
  • Brain metastases
  • Less than 28 days since last treatment used to treat the disease
  • Considered a poor medical risk due to a serious uncontrolled disorder
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Germany,   Israel,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT00628251
D0810C00012
Yes
AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Stan Kaye, BSc, MB, FRCP, FRCR, SMedSCi Royal Marsden NHS Foundation Trust
AstraZeneca
November 2014

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