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Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00912743
First received: May 28, 2009
Last updated: September 22, 2016
Last verified: September 2016
Results First Received: January 13, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Intervention: Drug: olaparib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Target accrual: 54 subjects. MSI-H group: 15; non-MSI-H group: 39. Pre-planned interim analysis of the non-MSI-H cohort, after 17 patients, stopped recruitment into that cohort. Recruitment to the MSI-H cohort continued.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with stage IV, measurable disseminated CRC incurable by surgery, with tumour progression following standard combination front-line or second-line chemotherapy, relapsed or recurrent disease within 6 months completing adjuvant or neoadjuvant chemotherapy and met all inclusion/exlusion criteria.

Reporting Groups
  Description
MSI-H MSI-H group receiving olaparib 400mg BID
Non-MSI-H Non-MSI-H group receiving olaparib 400mg BID

Participant Flow:   Overall Study
    MSI-H   Non-MSI-H
STARTED   13   20 
COMPLETED   0   0 
NOT COMPLETED   13   20 
Adverse Event                3                1 
Lack of Efficacy                9                18 
Toxicity                0                1 
End of treatment form was not collected                1                0 



  Baseline Characteristics
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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
MSI-H MSI-H group receiving olaparib 400mg BID
Non-MSI-H Non-MSI-H group receiving olaparib 400mg BID
Total Total of all reporting groups

Baseline Measures
   MSI-H   Non-MSI-H   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   20   33 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 51.77  (9.37)   61.80  (11.46)   57.85  (11.65) 
[1] Age (years) at screening
Gender [1] 
[Units: Participants]
     
Female   6   9   15 
Male   7   11   18 
[1] Gender, Male/Female
Race/Ethnicity, Customized [1] 
[Units: Participants]
     
White   10   19   29 
Black or African American   1   0   1 
Asian   1   0   1 
Other   1   1   2 
[1] Race


  Outcome Measures
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1.  Primary:   Tumour Response   [ Time Frame: From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months ]

2.  Secondary:   Progression Free Survival   [ Time Frame: From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months ]

3.  Secondary:   Overall Survival   [ Time Frame: Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed up to 35 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Angela Sawyer, Clinical Delivery Director
Organization: Astra Zeneca LLP
phone: +44 1625 512397
e-mail: angele.sawyer@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00912743     History of Changes
Other Study ID Numbers: D9010C00008
AGICC 09CRC01
Study First Received: May 28, 2009
Results First Received: January 13, 2015
Last Updated: September 22, 2016
Health Authority: United States: Food and Drug Administration