Overview

This trial is active, not recruiting.

Condition cancer
Treatment perifosine
Phase phase 1
Target JNK1
Sponsor AEterna Zentaris
Start date January 2012
End date May 2012
Trial size 24 participants
Trial identifier NCT01224730, Protocol 147

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Perifosine 100 mg orally daily under Fed and Fasted conditions
perifosine
100 mg daily

Primary Outcomes

Measure
To evaluate the effects of food on the PK profile and bioavailability of perifosine, and to evaluate the effects of perifosine treatment on ECG parameters
time frame: 24 days

Secondary Outcomes

Measure
To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies
time frame: Up to 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with advanced malignancies - Patients with adequate organ and marrow function Exclusion Criteria: - Patients previously treated with perifosine - Patients receiving any other chemotherapy, targeted agents, investigational agents or devices within four weeks (28 days) prior to Day 1 of study treatment

Additional Information

Official title A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by AEterna Zentaris.