Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00912743 |
|
Recruitment Status :
Completed
First Posted : June 3, 2009
Results First Posted : November 9, 2016
Last Update Posted : November 9, 2016
|
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Colorectal Cancer |
| Intervention |
Drug: olaparib |
| Enrollment | 33 |
Participant Flow
| Recruitment Details | 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 | 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. |
| Arm/Group Title | MSI-H | Non-MSI-H |
|---|---|---|
 Arm/Group Description |
MSI-H group receiving olaparib 400mg BID | Non-MSI-H group receiving olaparib 400mg BID |
| Period Title: Overall Study | ||
| Started | 13 | 20 |
| Completed | 0 | 0 |
| Not Completed | 13 | 20 |
| Reason Not Completed | ||
| Adverse Event | 3 | 1 |
| Lack of Efficacy | 9 | 18 |
| Toxicity | 0 | 1 |
| End of treatment form was not collected | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | MSI-H | Non-MSI-H | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
MSI-H group receiving olaparib 400mg BID | Non-MSI-H group receiving olaparib 400mg BID | Total of all reporting groups | |
| Overall Number of Baseline Participants | 13 | 20 | 33 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 13 participants | 20 participants | 33 participants | |
| 51.77 (9.37) | 61.80 (11.46) | 57.85 (11.65) | ||
|
[1]
Measure Description: Age (years) at screening
|
||||
|
Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 13 participants | 20 participants | 33 participants | |
| Female |
6 46.2%
|
9 45.0%
|
15 45.5%
|
|
| Male |
7 53.8%
|
11 55.0%
|
18 54.5%
|
|
|
[1]
Measure Description: Gender, Male/Female
|
||||
|
Race/Ethnicity, Customized
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 13 participants | 20 participants | 33 participants |
| White | 10 | 19 | 29 | |
| Black or African American | 1 | 0 | 1 | |
| Asian | 1 | 0 | 1 | |
| Other | 1 | 1 | 2 | |
|
[1]
Measure Description: Race
|
||||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Angela Sawyer, Clinical Delivery Director |
| Organization: | Astra Zeneca LLP |
| Phone: | +44 1625 512397 |
| EMail: | angele.sawyer@astrazeneca.com |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00912743 |
| Other Study ID Numbers: |
D9010C00008 AGICC 09CRC01 |
| First Submitted: | May 28, 2009 |
| First Posted: | June 3, 2009 |
| Results First Submitted: | January 13, 2015 |
| Results First Posted: | November 9, 2016 |
| Last Update Posted: | November 9, 2016 |