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

NCT00398879 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2018-03-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Perifosine

Perifosine 50 mg/d qd

DRUG

Capecitabine

Capecitabine 825 mg/m\^2 BID days 1 - 14 q 3 weeks

OTHER

Perifosine Placebo

Placebo to Perifosine 50 mg/d qd

Sponsors & Collaborators

  • AEterna Zentaris

    lead INDUSTRY

Principal Investigators

  • Craig Henderson, MD · Online Collaborative Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2010-12-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00398879 on ClinicalTrials.gov