Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
NCT ID: NCT01097018
Last Updated: 2013-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
468 participants
INTERVENTIONAL
2010-04-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Perifosine + Capecitabine
Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Capecitabine
1000 mg/m2 BID/ Days 1-14
Perifosine
50 mg daily x 21 days
Placebo + Capecitabine
Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Capecitabine
1000 mg/m2 BID/ Days 1-14
Placebo
1 pill daily x 21 days
Interventions
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Capecitabine
1000 mg/m2 BID/ Days 1-14
Perifosine
50 mg daily x 21 days
Placebo
1 pill daily x 21 days
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AEterna Zentaris
INDUSTRY
Responsible Party
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Principal Investigators
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Johanna Bendell, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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Alhambra, California, United States
Bakersfield, California, United States
La Verne, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Northridge, California, United States
Redondo Beach, California, United States
Santa Barbara, California, United States
Santa Maria, California, United States
Denver, Colorado, United States
Grand Junction, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Stamford, Connecticut, United States
Waterbury, Connecticut, United States
Fort Myers, Florida, United States
Hollywood, Florida, United States
Pembroke Pines, Florida, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Lawrenceville, Georgia, United States
Marietta, Georgia, United States
Roswell, Georgia, United States
Harvey, Illinois, United States
Park Ridge, Illinois, United States
South Bend, Indiana, United States
Terre Haute, Indiana, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Lansing, Michigan, United States
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Morristown, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Armonk, New York, United States
Great Neck, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
TN Oncology
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Beaumont, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Midland, Texas, United States
Tyler, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Countries
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References
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Results of the X-PECT study: A phase III randomized double-blind, placebo-controlled study of perifosine plus capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic colorectal cancer (mCRC). https://meetinglibrary.asco.org/content/98646-114 Abstract Number:LBA3501
Other Identifiers
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Protocol 343
Identifier Type: -
Identifier Source: org_study_id
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