Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer (ICEBERG 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494442
First received: June 27, 2007
Last updated: April 14, 2015
Last verified: April 2015
Results First Received: January 15, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Neoplasm
Intervention: Drug: KU-0059436 (AZD2281)(PARP inhibitor)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first patient was enrolled on June 11, 2007 and efficacy and safety data were collected up to the data cut-off of March 17, 2009. Patients were enrolled at 12 centres in 5 countries: Australia, Germany, Spain, Sweden and the USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two cohorts of women with Breast Cancer gene 1 (BRCA1)- or BRCA2-associated ovarian cancer who had failed at least one prior chemotherapy in the advanced/metastatic setting, were planned to receive olaparib 100 mg bd (n= up to 24) or 400 mg bd (n= up to 40). Enrolment to 2 cohorts was sequential with the 400 mg bd cohort being recruited first.

Reporting Groups
  Description
Olaparib 100 mg bd olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
Olaparib 400 mg bd olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily

Participant Flow:   Overall Study
    Olaparib 100 mg bd     Olaparib 400 mg bd  
STARTED     24 [1]   33 [1]
COMPLETED     7 [2]   17 [2]
NOT COMPLETED     17     16  
Death                 1                 1  
Lack of Efficacy                 16                 10  
Adverse Event                 0                 2  
Physician Decision                 0                 1  
Non-compliance                 0                 1  
Intercurrent illness                 0                 1  
[1] Patients received treatment
[2] Patients completed the full study schedule (168 days treatment)



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Olaparib 100 mg bd olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
Olaparib 400 mg bd olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
Total Total of all reporting groups

Baseline Measures
    Olaparib 100 mg bd     Olaparib 400 mg bd     Total  
Number of Participants  
[units: participants]
  24     33     57  
Age  
[units: Year]
Mean (Standard Deviation)
  55.6  (8.02)     56.8  (10.49)     56  (9)  
Gender  
[units: Participants]
     
Female     24     33     57  
Male     0     0     0  
BRCA status  
[units: Participants]
     
BRCA1     19     21     40  
BRCA2     5     12     17  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   Clinical Benefit (CB)   [ Time Frame: End of study ]

3.  Secondary:   Duration of Response   [ Time Frame: End of study ]

4.  Secondary:   Best Percentage Change in Tumour Size   [ Time Frame: End of study ]

5.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: End of study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00494442     History of Changes
Other Study ID Numbers: KU36-58, D0810C00009
Study First Received: June 27, 2007
Results First Received: January 15, 2015
Last Updated: April 14, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Spain: Spanish Agency of Medicines