Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer (X-PECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01097018
First received: March 30, 2010
Last updated: June 25, 2013
Last verified: June 2013

March 30, 2010
June 25, 2013
April 2010
April 2012   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01097018 on ClinicalTrials.gov Archive Site
Progression-free Survival [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
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

The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: Capecitabine
    1000 mg/m2 BID/ Days 1-14
  • Drug: Perifosine
    50 mg daily x 21 days
  • Drug: Placebo
    1 pill daily x 21 days
  • Active Comparator: Perifosine + Capecitabine
    Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
    Interventions:
    • Drug: Capecitabine
    • Drug: Perifosine
  • Placebo Comparator: Placebo + Capecitabine
    Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
    Interventions:
    • Drug: Capecitabine
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
468
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01097018
Protocol 343
Yes
AEterna Zentaris
AEterna Zentaris
Not Provided
Principal Investigator: Johanna Bendell, MD SCRI Development Innovations, LLC
AEterna Zentaris
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP