MedTrace Logo

A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia

NCT00398710 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-03-15

No results posted yet for this study

Summary

This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive. In addition, it will assess toxicity of this drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks.

Conditions

  • Waldenström's Macroglobulinemia

Interventions

DRUG

Perifosine

150 mg daily (100 mg daily in case of dose reduction)

Sponsors & Collaborators

Principal Investigators

  • Irene M Ghobrial, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2011-08-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00398710 on ClinicalTrials.gov