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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 May 2013 |
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Main ID: |
NCT01097018 |
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Date of registration:
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30/03/2010 |
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Primary sponsor: |
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Public title:
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Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
X-PECT |
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Scientific title:
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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 |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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468 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01097018 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Israel
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United States
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Contacts
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Name:
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Johanna Bendell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sarah Cannon Research Institute |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Drug: Capecitabine + Perifosine or Placebo
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Primary Outcome(s)
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Overall Survival
[Time Frame: Monthly]
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Secondary Outcome(s)
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Progression-free Survival
[Time Frame: Every 6 weeks]
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Secondary ID(s)
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Protocol 343
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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