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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response as assessed by RECIST

Outcome Time Frame:

6 weekly

Safety Issue:

No

Principal Investigator

Lawrence P Leichman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aptium Oncology Gastrointestinal Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

D9010C00008

NCT ID:

NCT00912743

Start Date:

May 2009

Completion Date:

March 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • Olaparib
  • MSI status
  • Stage IV
  • Measurable Colorectal Cancer
  • Stratified by MSI Status
  • Colorectal Neoplasms
  • Microsatellite Instability

Name

Location

Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteLewes, Delaware  
Research SiteBoca Raton, Florida  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee  
Research SiteAuburn, Washington