MedTrace Logo

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

NCT00399789 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2018-02-22

No results posted yet for this study

Summary

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Perifosine

Perifosine will be tested in 3 dose forms

Sponsors & Collaborators

  • AEterna Zentaris

    lead INDUSTRY

Principal Investigators

  • David Spigel, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2010-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399789 on ClinicalTrials.gov