Phase 2
N=33
Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00912743 ↗Enrolled (actual)
33
Serious AEs
27.3%
Results posted
Nov 2016
Primary outcome: Primary: Tumour Response — 0; 0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- olaparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumour Response |
0; 0 | — |
| SECONDARY Progression Free Survival |
61; 55 | — |
| SECONDARY Overall Survival |
248; 290.5 | — |
Summary
This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to determine whether olaparib will have a beneficial effect on the patient's cancer by causing a response and increasing the time it takes for the cancer to progress.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00912743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.