Trial record 1 of 3 for:    perifosine AND colorectal
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Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer (X-PECT)

This study has been completed.
Information provided by (Responsible Party):
AEterna Zentaris Identifier:
First received: March 30, 2010
Last updated: June 25, 2013
Last verified: June 2013
The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.

Condition Intervention Phase
Colorectal Cancer
Drug: Capecitabine
Drug: Perifosine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:

Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 468
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Perifosine + Capecitabine
Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Drug: Capecitabine
1000 mg/m2 BID/ Days 1-14
Drug: Perifosine
50 mg daily x 21 days
Placebo Comparator: Placebo + Capecitabine
Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Drug: Capecitabine
1000 mg/m2 BID/ Days 1-14
Drug: Placebo
1 pill daily x 21 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01097018

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Sponsors and Collaborators
AEterna Zentaris
Principal Investigator: Johanna Bendell, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
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). Abstract Number:LBA3501

Responsible Party: AEterna Zentaris Identifier: NCT01097018     History of Changes
Other Study ID Numbers: Protocol 343 
Study First Received: March 30, 2010
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 07, 2016