Clinical trial NCT00912743: Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Olaparib
MSI status
Stage IV
Measurable Colorectal Cancer
Stratified by MSI Status
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Tumour Response
timeFrame: 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
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 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
measure: Overall Survival
timeFrame: 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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Newark
country: United States
facility: Research Site
state: Delaware
city: New York
country: United States
facility: Research Site
state: New York
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Aptium Oncology Gastrointestinal Cancer Consortium
name: Lawrence P Leichman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aptium Oncology Gastrointestinal Cancer Consortium
name: Bert H O'Neil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Jane Robertson, BSc, MBCHB, MD
role: STUDY_DIRECTOR
References: