Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer - Full Text View

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

This study is ongoing, but not recruiting participants.

First Received on March 30, 2010. Last Updated on October 16, 2011 History of Changes

Sponsor:	Keryx / AOI Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Keryx / AOI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01097018

Purpose

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 + Perifosine or Placebo	Phase III

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:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Capecitabine Perifosine

U.S. FDA Resources

Further study details as provided by Keryx / AOI Pharmaceuticals, Inc.:

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 ]

Estimated Enrollment:	430
Study Start Date:	April 2010
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	December 2011 (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 + Perifosine or Placebo Perifosine or placebo 1 pill daily in combination with capecitabine therapy
Placebo Comparator: Placebo + Capecitabine Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days	Drug: Capecitabine + Perifosine or Placebo Perifosine or placebo 1 pill daily in combination with capecitabine therapy

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097018

Show 65 Study Locations

Sponsors and Collaborators

Keryx / AOI Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Johanna Bendell, MD

Sarah Cannon Research Institute

More Information

No publications provided

Responsible Party:	Keryx / AOI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01097018 History of Changes
Other Study ID Numbers:	Protocol 343
Study First Received:	March 30, 2010
Last Updated:	October 16, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012