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

June 25, 2013 updated by: AEterna Zentaris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
468

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Alhambra, California, United States, 91801
      • Bakersfield, California, United States, 93309
      • La Verne, California, United States, 91750
      • Long Beach, California, United States, 90813
      • Los Angeles, California, United States, 90095
      • Northridge, California, United States, 91325
      • Redondo Beach, California, United States, 90277
      • Santa Barbara, California, United States, 93105
      • Santa Maria, California, United States, 93454
    • Colorado
      • Denver, Colorado, United States, 80218
      • Grand Junction, Colorado, United States, 81501
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
      • Stamford, Connecticut, United States, 06902
      • Waterbury, Connecticut, United States, 06708
    • Florida
      • Fort Myers, Florida, United States, 33916
      • Hollywood, Florida, United States, 33021
      • Pembroke Pines, Florida, United States, 33028
    • Georgia
      • Athens, Georgia, United States, 30607
      • Atlanta, Georgia, United States, 30341
      • Lawrenceville, Georgia, United States, 30046
      • Marietta, Georgia, United States, 30060
      • Roswell, Georgia, United States, 30076
    • Illinois
      • Harvey, Illinois, United States, 60467
      • Park Ridge, Illinois, United States, 60068
    • Indiana
      • South Bend, Indiana, United States, 44601
      • Terre Haute, Indiana, United States, 47802
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Bethesda, Maryland, United States, 20817
    • Michigan
      • Lansing, Michigan, United States, 48912
    • Mississippi
      • Jackson, Mississippi, United States, 39202
      • Tupelo, Mississippi, United States, 38801
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • Nevada
      • Henderson, Nevada, United States, 89052
      • Las Vegas, Nevada, United States, 89169
    • New Jersey
      • Morristown, New Jersey, United States, 07960
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
      • Albuquerque, New Mexico, United States, 87110
    • New York
      • Armonk, New York, United States, 10504
      • Great Neck, New York, United States, 11042
      • New Hyde Park, New York, United States, 11040
      • New York City, New York, United States, 10016
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
    • North Dakota
      • Bismark, North Dakota, United States, 58504
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Columbus, Ohio, United States, 43210
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • South Carolina
      • Columbia, South Carolina, United States, 29210
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Memphis, Tennessee, United States, 38120
      • Nashville, Tennessee, United States, 37203
        • TN Oncology
    • Texas
      • Abilene, Texas, United States, 79606
      • Austin, Texas, United States, 78731
      • Beaumont, Texas, United States, 77702
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75230
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
      • Midland, Texas, United States, 79701
      • Tyler, Texas, United States, 75702
    • Virginia
      • Richmond, Virginia, United States, 23230
    • Washington
      • Seattle, Washington, United States, 98104
      • Spokane, Washington, United States, 99208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival
Time Frame: Monthly
Monthly

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Progression-free Survival
Time Frame: Every 6 weeks
Every 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AEterna Zentaris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Protocol 343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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