A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer

February 20, 2018 updated by: AEterna Zentaris

This is a study of the drug perifosine that consists of 2 parts. The first part of this study was designed to determine the highest dose of perifosine that can be administered to people every week without severe or prolonged nausea, vomiting and diarrhea. This study started with patients taking 900 mg/week and went up to 1800 mg/week. Part I of this study is completed. The MTD had been determined and incorporated in Part II.

The goals in Part II are to:

  1. Compare the gastrointestinal toxicity of 3 different dose-schedules and
  2. Obtain preliminary information on the response rate of perifosine in non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of Part I of this study was to determine the maximum dose of perifosine that can be administered with tolerable gastrointestinal toxicity; and to obtain preliminary information on the response rate of perifosine in non-small cell lung cancer. In addition, the trial was and is designed to provide some insight into the nature of the anti-tumor effect, the time to response, and dose-schedules that should be used in future trials.

Part 2 - In the second part of this study, patients will be randomized to one of 3 dose-schedules of perifosine and to test if the response rate of perifosine in non small cell lung cancer is > 10% in any of the 3 arms of the study. The study is not designed to compare the response rates in the 3 arms of the trial, but toxicities will be compared. The regimens are:

  • A weekly dose of 900 mg to be divided into three doses of 300 mg each. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 1,200 mg divided into four doses of 300 mg.
  • A daily dose of 150 mg to be divided into three doses of 50 mg each. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 200 mg divided into four doses of 50 mg.
  • A daily dose of 150 mg to be given in one dose at bedtime. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 200 mg to be given in one dose at bedtime.

Patients receiving weekly perifosine will receive prophylactic antiemetics. Patients receiving daily perifosine will not routinely receive prophylactic antiemetics unless they experience nausea. All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on treatment with doses delayed or reduced.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2
  • Phase 1

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
      • Pomona, California, United States, 91767
        • AOI Pharmaceuticals Investigative Site
    • Florida
      • Aventura, Florida, United States, 33180
        • AOI Pharmaceuticals Investigative Site
      • Hollywood, Florida, United States, 33021
        • AOI Pharmaceuticals Investigative Site
      • Lakeland, Florida, United States, 33805
        • AOI Pharmaceuticals Investigative Site
      • Ormond Beach, Florida, United States, 32174
        • AOI Pharmaceuticals Investigative Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30045
        • AOI Pharmaceuticals Investigative Site
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • AOI Pharmaceuticals Investigative Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • AOI Pharmaceuticals Investigative Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • AOI Pharmaceuticals Investigative Site
      • Kalamazoo, Michigan, United States, 49048
        • AOI Pharmaceuticals Investigative Site
    • Montana
      • Billings, Montana, United States, 59101
        • AOI Pharmaceuticals Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • 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
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • AOI Pharmaceuticals Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • AOI Pharmaceuticals Investigative Site
      • Nashville, Tennessee, United States, 37203
        • AOI Pharmaceuticals Investigative Site
    • Texas
      • Dallas, Texas, United States, 75246
        • AOI Pharmaceuticals Investigative Site
      • Dallas, Texas, United States, 75237
        • AOI Pharmaceuticals Investigative Site
      • Tyler, Texas, United States, 75702
        • 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:

  • Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer, must have progressed despite standard therapy and must not be candidates for surgical or combined modality therapy.
  • At least 18 years of age.
  • Patients should have received at least one but no more than two prior chemotherapy regimens for metastatic disease. The study chairman or medical monitor will consider extenuating circumstances for patients with more than two such regimens.
  • Patients must have measurable disease. Since the outcome for a patient is to be based on response using RECIST criteria, the patient must have at least one measurable lesion that can be accurately measured in at least one dimension and fit one of the following criteria: longest diameter 20 mm using conventional techniques or 10 mm with spiral CT scan.
  • Patients must have a life expectancy of more than 3 months.
  • Patients should have a performance status of 0 to 1 according to the ECOG criteria. However, patients with ECOG performance status of 2 may be admitted with approval from the study chairman or medical monitor.
  • Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy and for four weeks after the completion of treatment.
  • Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • Patients with rapidly progressing disease, as defined by progression within 12 weeks of initiation of the previous regimen.
  • Patients receiving any other investigational agents or devices.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine.
  • 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.

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Perifosine 150 mg qd
A daily dose of 150 mg to be given in one dose at bedtime. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 200 mg to be given in one dose at bedtime.
Drug: Perifosine
Perifosine will be tested in 3 dose forms
ACTIVE_COMPARATOR: Perifosine 900 mg per week
A weekly dose of 900 mg to be divided into three doses of 300 mg each. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 1,200 mg divided into four doses of 300 mg.
Drug: Perifosine
Perifosine will be tested in 3 dose forms
ACTIVE_COMPARATOR: Perifosine 50 mg tid
A daily dose of 150 mg to be divided into three doses of 50 mg each. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 200 mg divided into four doses of 50 mg.
Drug: Perifosine
Perifosine will be tested in 3 dose forms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal toxicity of 3 different dose-schedules
Time Frame: 12 weeks
The frequency of grade 2 or greater gastrointestinal toxicities between the 3 arms of the study will be observed and used to determine the best regimen
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary information on response rate
Time Frame: 3 months
To test if the response rate of perifosine in non small cell lung cancer is > 10% in any of the 3 arms of the study.
3 months

Collaborators and Investigators

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

Sponsor

AEterna Zentaris

Investigators

  • Principal Investigator: David Spigel, MD, SCRI Development Innovations, LLC

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

  • Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13063

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

September 1, 2004

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

November 13, 2006

First Submitted That Met QC Criteria

November 13, 2006

First Posted (ESTIMATE)

November 15, 2006

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perifosine 201

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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