Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients

March 12, 2018 updated by: AEterna Zentaris

A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or capecitabine alone.

The effects of perifosine may be manifested by increased time to progression, tumor regression reflected in partial or complete responses, or a combination of these outcomes. The primary goal of this trial is to obtain a preliminary and objective assessment of the effects of perifosine on time to progression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. If there is any evidence of improved time to progression in any tumor type with any of the drugs to be evaluated, the initial study or component(s) of the study will be expanded to increase the certainty that this is an effect of perifosine. If there is compelling evidence of benefit from this study, a phase 3 trial will be conducted to obtain proof of principle.

Primary Study Objectives:

To determine the time to tumor progression when receiving single agent chemotherapy (capecitabine) in combination with perifosine in comparison to patients receiving single agent chemotherapy (capecitabine) alone (i.e., with placebo).

Secondary Study Objectives:

  • To determine the toxicity of single agent chemotherapy in combination with perifosine.
  • To compare the time to progression of chemotherapy in combination with placebo to historical experience.
  • Overall survival will also be evaluated.

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Phase 2

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
    • Arizona
      • Tucson, Arizona, United States, 85704
        • AOI Pharmaceuticals Investigative Site
    • California
      • Beverly Hills, California, United States, 90211
        • AOI Pharmaceuticals Investigative Site
      • Deer Park, California, United States, 94574
        • AOI Pharmaceuticals Investigative Site
      • Monterey, California, United States, 93940
        • AOI Pharmaceuticals Investigative Site
      • Newport Beach, California, United States, 92663
        • AOI Pharmaceuticals Investigative Site
      • Pomona, California, United States, 91767
        • AOI Pharmaceuticals Investigative Site
      • Santa Rosa, California, United States, 95403
        • AOI Pharmaceuticals Investigative Site
      • Soquel, California, United States, 95703
        • AOI Pharmaceuticals Investigative Site
      • Stockton, California, United States, 95207
        • AOI Pharmaceuticals Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • AOI Pharmaceuticals Investigative Site
      • Greeley, Colorado, United States, 80631
        • AOI Pharmaceuticals Investigative Site
    • Connecticut
      • Middletown, Connecticut, United States, 06457
        • AOI Pharmaceuticals Investigative Site
      • Norwich, Connecticut, United States, 06360
        • AOI Pharmaceuticals Investigative Site
    • Florida
      • Aventura, Florida, United States, 33180
        • AOI Pharmaceuticals Investigative Site
      • Coral Springs, Florida, United States, 33065
        • AOI Pharmaceuticals Investigative Site
      • Lake City, Florida, United States, 32055
        • AOI Pharmaceuticals Investigative Site
      • Miami, Florida, United States, 33176
        • AOI Pharmaceuticals Investigative Site
      • Ormond Beach, Florida, United States, 32174
        • AOI Pharmaceuticals Investigative Site
      • Sebastian, Florida, United States, 32958
        • AOI Pharmaceuticals Investigative Site
      • Vero Beach, Florida, United States, 32960
        • AOI Pharmaceuticals Investigative Site
    • Georgia
      • Augusta, Georgia, United States, 30904
        • AOI Pharmaceuticals Investigative Site
      • Lawrenceville, Georgia, United States, 30045
        • AOI Pharmaceuticals Investigative Site
      • Marietta, Georgia, United States, 30060
        • AOI Pharmaceuticals Investigative Site
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • AOI Pharmaceuticals Investigative Site
      • Park Ridge, Illinois, United States, 60068
        • AOI Pharmaceuticals Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • AOI Pharmaceuticals Investigative Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • AOI Pharmaceuticals Investigative Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • AOI Pharmaceuticals Investigative Site
      • Kalamazoo, Michigan, United States, 49048
        • AOI Pharmaceuticals Investigative Site
    • Missouri
      • Branson, Missouri, United States, 65616
        • AOI Pharmaceuticals Investigative Site
    • Montana
      • Billings, Montana, United States, 59103
        • AOI Pharmaceuticals Investigative Site
      • Great Falls, Montana, United States, 59405
        • AOI Pharmaceuticals Investigative Site
    • New York
      • Albany, New York, United States, 12208
        • AOI Pharmaceuticals Investigative Site
      • Armonk, New York, United States, 10504
        • AOI Pharmaceuticals Investigative Site
      • Great Neck, New York, United States, 11042
        • AOI Pharmaceuticals Investigative Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • AOI Pharmaceuticals Investigative Site
    • Ohio
      • Dayton, Ohio, United States, 45409
        • AOI Pharmaceuticals Investigative Site
    • Pennsylvania
      • Pottsville, Pennsylvania, United States, 17901
        • AOI Pharmaceuticals Investigative Site
      • Sayre, Pennsylvania, United States, 18840
        • AOI Pharmaceuticals Investigative Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • AOI Pharmaceuticals Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • AOI Pharmaceuticals Investigative Site
      • Memphis, Tennessee, United States, 38120
        • AOI Pharmaceuticals Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • AOI Pharmaceuticals Investigative Site
      • Dallas, Texas, United States, 75246
        • AOI Pharmaceuticals Investigative Site
      • Tyler, Texas, United States, 75702
        • AOI Pharmaceuticals Investigative Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • AOI Pharmaceuticals Investigative Site
      • Norfolk, Virginia, United States, 23502
        • AOI Pharmaceuticals Investigative Site
    • Washington
      • Spokane, Washington, United States, 99218
        • AOI Pharmaceuticals Investigative Site
    • Wisconsin
      • Appleton, Wisconsin, United States, 54915
        • AOI Pharmaceuticals Investigative Site

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. In the opinion of the treating physician, treatment with one of the following regimens should represent an appropriate treatment for the patient.

    - Capecitabine 825 mg/m2 BID days 1 - 14 q 3 weeks

  2. Patients should have a histologically or cytologically confirmed diagnosis of colorectal cancer.
  3. Patients must have received at least one but no more than two prior chemotherapy regimen(s) for the treatment of metastatic or recurrent disease.

  4. ECOG performance status 0 or 1.

    • Leukocytes >= 4,000/μL
    • absolute neutrophil count >= 1,500/ μL
    • platelets >= 100,000/ μL
    • HCT > 28% (with or without growth factor support)
    • Creatinine <= 2.5 mg/dl
    • total bilirubin < 1.5 x upper limit of normal
    • transaminase < 2.5 x upper limit of normal
  5. Patients must have recovered from acute toxicity-excluding alopecia-related to prior therapy, including surgery or radiotherapy.
  6. Patients with brain metastases may be admitted, provided the disease has been treated and been stable for 2 months.
  7. Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients receiving any other investigational agents or devices.
  2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements.
  4. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study due to potential pharmacokinetic interactions with perifosine.
  5. Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Assoc. class II - IV congestive heart failure.
  6. Female patients who are pregnant or lactating are ineligible.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Perifosine + Capecitabine
Perifosine 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
Drug: Perifosine
Perifosine 50 mg/d qd
Other Names:
  • D-21266
  • KRX-0401
Drug: Capecitabine
Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks
Placebo Comparator: Arm 2: Perifosine Placebo + Capecitabine
Perifosine Placebo 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
Drug: Capecitabine
Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks
Other: Perifosine Placebo
Placebo to Perifosine 50 mg/d qd
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of perifosine on time to progression
Time Frame: Every 12 weeks
Time to progression will be measured from the first day of study drug until progression.
Every 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity
Time Frame: Every 12 weeks
Determination of the toxicity of single agent chemotherapy in combination with perifosine. Toxicity evaluation is to be performed throughout the study.
Every 12 weeks
Comparison of time to progression to historical experience
Time Frame: Every 12 weeks
To compare the time to progression of chemotherapy in combination with placebo to historical experience.
Every 12 weeks

Collaborators and Investigators

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

Sponsor

AEterna Zentaris

Investigators

  • Study Chair: Craig Henderson, MD, Online Collaborative Oncology Group

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

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

August 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 6, 2006

First Submitted That Met QC Criteria

November 10, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perifosine 211

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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