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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00628251
First received: February 26, 2008
Last updated: February 13, 2013
Last verified: February 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 26, 2008 | ||||||||
| Last Updated Date | February 13, 2013 | ||||||||
| Start Date ICMJE | July 2008 | ||||||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT00628251 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Comparison of safety and tolerability [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Comparison of safety and tolerability [ Designated as safety issue: Yes ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Ovarian Neoplasms | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 97 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States, Australia, Belgium, Germany, Israel, Poland, Spain, Sweden, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00628251 | ||||||||
| Other Study ID Numbers ICMJE | D0810C00012 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | AstraZeneca | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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