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A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer


Inclusion Criteria:



- Patients must have failed available therapy for the treatment of advanced colorectal
cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for
K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab)
containing therapies.

- For oxaliplatin-based therapy, failure of therapy will also include patients who had
oxaliplatin discontinued secondary to toxicity.

- No prior exposure to capecitabine in the metastatic colorectal cancer setting, except
limited-course radiosensitizing capecitabine

- Patients must have at least one measurable lesion by RECIST criteria

Exclusion Criteria:

- Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe
reaction to 5-FU

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Monthly

Safety Issue:

No

Principal Investigator

Johanna Bendell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

Protocol 343

NCT ID:

NCT01097018

Start Date:

April 2010

Completion Date:

April 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Albuquerque, New Mexico  87131-5636
Denver, Colorado  
Baltimore, Maryland  21287
Charlotte, North Carolina  
Indianapolis, Indiana  
Charleston, South Carolina  
Tulsa, Oklahoma  
Las Vegas, Nevada  89109
Jackson, Mississippi  
Yale University School Of MedicineNew Haven, Connecticut  06520
Bismarck, North Dakota  58501
TN OncologyNashville, Tennessee  37203