|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00912743 |
|
Date of registration:
|
28/05/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
|
|
Scientific title:
|
A Phase II, Open-Label, Multicenter Trial to Assess the Efficacy and Safety of the PARP Inhibitor, Olaparib, Alone in Previously-Treated Patients With Stage IV, Measurable Colorectal Cancer, Stratified by MSI Status |
|
Date of first enrolment:
|
May 2009 |
|
Target sample size:
|
71 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00912743 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Bert H O'Neil, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aptium Oncology Gastrointestinal Cancer Consortium |
|
|
Name:
|
Lawrence P Leichman, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aptium Oncology Gastrointestinal Cancer Consortium |
|
|
Name:
|
Jane Robertson, BSc, MBCHB, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AstraZeneca |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients will have measurable disseminated colorectal cancer that is incurable by
surgery
- Patients will have had tumor progression following standard combination front-line or
second-line chemotherapy.
- CRC patients who have relapsed or recurrent disease within six months after
completing adjuvant or neoadjuvant chemotherapy
Exclusion Criteria:
- Previous treatment with PARP inhibitors, including olaparib.
- Patients with symptomatic, uncontrolled brain metastases.
- Patients receiving any chemotherapy, radiotherapy (except for palliative reasons),
within 4 weeks from the last dose prior to study entry (or a longer period depending
on the defined characteristics of the agents used).
- Patients who are unable to swallow orally administered medication.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Colorectal Cancer
|
|
Intervention(s)
|
|
Drug: olaparib
|
|
Primary Outcome(s)
|
|
Tumor response as assessed by RECIST
[Time Frame: 6 weekly]
|
|
Secondary ID(s)
|
|
AGICC 09CRC01
|
|
D9010C00008
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|