Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
X-PECT
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
1 other identifier
interventional
468
1 country
65
Brief Summary
The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 colorectal-cancer
Started Apr 2010
Shorter than P25 for phase_3 colorectal-cancer
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2010
CompletedFirst Posted
Study publicly available on registry
April 1, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJuly 2, 2013
June 1, 2013
2 years
March 30, 2010
June 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Monthly
Secondary Outcomes (1)
Progression-free Survival
Every 6 weeks
Study Arms (2)
Perifosine + Capecitabine
ACTIVE COMPARATORPerifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Placebo + Capecitabine
PLACEBO COMPARATORPlacebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AEterna Zentarislead
Study Sites (65)
Unknown Facility
Alhambra, California, 91801, United States
Unknown Facility
Bakersfield, California, 93309, United States
Unknown Facility
La Verne, California, 91750, United States
Unknown Facility
Long Beach, California, 90813, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Northridge, California, 91325, United States
Unknown Facility
Redondo Beach, California, 90277, United States
Unknown Facility
Santa Barbara, California, 93105, United States
Unknown Facility
Santa Maria, California, 93454, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Grand Junction, Colorado, 81501, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Unknown Facility
Stamford, Connecticut, 06902, United States
Unknown Facility
Waterbury, Connecticut, 06708, United States
Unknown Facility
Fort Myers, Florida, 33916, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
Pembroke Pines, Florida, 33028, United States
Unknown Facility
Athens, Georgia, 30607, United States
Unknown Facility
Atlanta, Georgia, 30341, United States
Unknown Facility
Lawrenceville, Georgia, 30046, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Roswell, Georgia, 30076, United States
Unknown Facility
Harvey, Illinois, 60467, United States
Unknown Facility
Park Ridge, Illinois, 60068, United States
Unknown Facility
South Bend, Indiana, 44601, United States
Unknown Facility
Terre Haute, Indiana, 47802, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Bethesda, Maryland, 20817, United States
Unknown Facility
Lansing, Michigan, 48912, United States
Unknown Facility
Jackson, Mississippi, 39202, United States
Unknown Facility
Tupelo, Mississippi, 38801, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Lincoln, Nebraska, 68510, United States
Unknown Facility
Henderson, Nevada, 89052, United States
Unknown Facility
Las Vegas, Nevada, 89169, United States
Unknown Facility
Morristown, New Jersey, 07960, United States
Unknown Facility
Albuquerque, New Mexico, 87106, United States
Unknown Facility
Albuquerque, New Mexico, 87110, United States
Unknown Facility
Armonk, New York, 10504, United States
Unknown Facility
Great Neck, New York, 11042, United States
Unknown Facility
New Hyde Park, New York, 11040, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Charlotte, North Carolina, 28204, United States
Unknown Facility
Bismarck, North Dakota, 58504, United States
Unknown Facility
Fargo, North Dakota, 58122, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Columbia, South Carolina, 29210, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
TN Oncology
Nashville, Tennessee, 37203, United States
Unknown Facility
Abilene, Texas, 79606, United States
Unknown Facility
Austin, Texas, 78731, United States
Unknown Facility
Beaumont, Texas, 77702, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Midland, Texas, 79701, United States
Unknown Facility
Tyler, Texas, 75702, United States
Unknown Facility
Richmond, Virginia, 23230, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Spokane, Washington, 99208, United States
Related Publications (1)
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
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johanna Bendell, MD
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2010
First Posted
April 1, 2010
Study Start
April 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
July 2, 2013
Record last verified: 2013-06