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A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies

NCT01224730 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-03-14

No results posted yet for this study

Summary

This is a Phase I study which will analyze any food-drug effects as well as QTc effects of perifosine. Safety and efficacy will also be evaluated.

Patients who complete the first 24 days on single agent perifosine may have the opportunity to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine + perifosine; or 3) switch to the combination of sorafenib + perifosine.

Conditions

Interventions

DRUG

perifosine

100 mg daily

Sponsors & Collaborators

  • AEterna Zentaris

    lead INDUSTRY

Principal Investigators

  • Ed Cullen, PhD · Keryx / AOI Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-24
Primary Completion
2013-11-04
Completion
2013-11-04

Countries

  • United States

Study Locations

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Entities

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 NCT01224730 on ClinicalTrials.gov