Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer (ICEBERG 2)
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ClinicalTrials.gov Identifier: NCT00494442 |
Recruitment Status :
Completed
First Posted : June 29, 2007
Results First Posted : January 26, 2015
Last Update Posted : August 1, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Neoplasm | Drug: KU-0059436 (AZD2281)(PARP inhibitor) | Phase 2 |
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer |
Actual Study Start Date : | June 11, 2007 |
Actual Primary Completion Date : | March 17, 2009 |
Actual Study Completion Date : | July 20, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: KU-0059436 (AZD2281) 100 mg BID |
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Name: Olaparib |
Experimental: KU-0059436 (AZD2281) 400 mg BID |
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral |
- Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Clinical Benefit (CB) [ Time Frame: End of study ]Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)
- Duration of Response [ Time Frame: End of study ]Duration of response to olaparib
- Best Percentage Change in Tumour Size [ Time Frame: End of study ]The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
- Progression-Free Survival (PFS) [ Time Frame: End of study ]Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression.

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Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Advanced ovarian cancer with positive BRCA1 or BRCA2 status
- Failed at least one prior chemotherapy
- In investigators opinion, no curative standard therapy exists
- Measurable disease
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494442
United States, California | |
Research Site | |
Los Angeles, California, United States, 90048 | |
Research Site | |
San Francisco, California, United States, 94115 | |
United States, Massachusetts | |
Research Site | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Research Site | |
New York, New York, United States, 10065 | |
United States, Texas | |
Research Site | |
Houston, Texas, United States, 77030 | |
Australia | |
Research Site | |
Melbourne, Parkville, Australia, VIC 3050 | |
Research Site | |
Melbourne, Australia, 3000 | |
Research Site | |
Randwick, Australia, 2031 | |
Germany | |
Research Site | |
Köln, Germany, 50931 | |
Spain | |
Research Site | |
Hospitalet deLlobregat, Spain, 08907 | |
Sweden | |
Research Site | |
Lund, Sweden, S-221 85 |
Study Director: | James Carmichael, BSc MBChB MD FRCP | KuDOS Pharmaceuticals Limited | |
Principal Investigator: | Andrew Tutt, PhD MRCP FRCR | Guy's and St Thomas's NHS Foundation Trust, London, UK |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00494442 |
Other Study ID Numbers: |
KU36-58 D0810C00009 |
First Posted: | June 29, 2007 Key Record Dates |
Results First Posted: | January 26, 2015 |
Last Update Posted: | August 1, 2018 |
Last Verified: | June 2018 |
Advanced ovarian cancer Poly(ADP ribose) polymerases KU-0059436 |
AZD2281 BRCA1 protein BRCA2 protein |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Olaparib Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |