Trial intelligence / Profile preview

Perifosine in Soft Tissue Sarcoma

NCT00064324Phase 2

Key facts

Status: Completed
Start: Jun 2003
Primary completion: Nov 2005
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules

Drugs: perifosine
Conditions: soft tissue sarcoma (STS)

Overview

Phase 2, open-label, single-arm trial of perifosine in soft tissue sarcoma (STS), sponsored by National Cancer Institute. Primary endpoint: Progression-Free Rate at 6 months. Started Jun 2003; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Arm I
Patients receive oral perifosine.

Who it enrols

Patients with histologically confirmed advanced soft tissue sarcoma, measurable disease, adequate organ function, ECOG PS 0-1, and life expectancy >= 12 weeks. Excludes pregnant/nursing women, patients with >= 3 prior cytotoxic chemotherapy regimens for metastatic sarcoma, uncontrolled brain metastases, active infections, or HIV-positive patients on combination anti-retroviral therapy.

Endpoints

Primary

Progression-Free Rate6 months

Secondary

Overall Survivalup to 5 years
Time to Progressionup to 5 years
Duration of Responseup to 5 years
Time to Treatment Failureup to 5 years
Pharmacokineticsday 1 of courses 2-6

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