Overview

This trial is active, not recruiting.

Conditions non small cell lung cancer, solid tumors, metastatic breast cancer, sarcomas
Treatments perifosine
Targets JNK1, AKT, NF-kB
Sponsor AEterna Zentaris
Start date May 2008
End date December 2012
Trial size 50 participants
Trial identifier NCT00847366, Perifosine 534

Summary

This is an open label trial for patients currently enrolled in other perifosine trials.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Perifosine 201: A Phase 1/2 trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer
perifosine
All patients should continue therapy on their current regimen until disease progression.
(Experimental)
Perifosine 206: A Randomized Phase II Trial of Three Doses of Perifosine in Combination With Trastuzumab
perifosine
All patients should continue therapy on their current regimen until disease progression
(Experimental)
Perifosine 207: A Phase IIA Trial of Two Schedules of Perifosine
perifosine
All patients should continue therapy on their current regimen until disease progression
(Experimental)
Perifosine 208: A Phase II Trial of Two Schedules of Perifosine in Combination with Endocrine Therapy for Patients with Estrogen Receptor or Progesterone Receptor Positive Metastatic Breast Cancer
perifosine
All patients should continue therapy on their current regimen until disease progression
(Experimental)
Perifosine 209: A Phase II Trial of Perifosine in Patients with Sarcomas
perifosine
All patients should continue therapy on their current regimen until disease progression

Primary Outcomes

Measure
To evaluate the safety and tolerability of perifosine as a single agent as well as in combination with hormonal therapies or trastuzamab.
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients must be currently receiving treatment with perifosine on a previously approved protocol. - Patients must have had at least one evaluation following the initiation of treatment and have stable disease, partial response or complete response. - Patient is willing to sign a new consent

Additional Information

Official title An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
Description Perifosine is an oral anticancer agent with limited toxicity and a novel mechanism of action that is distinctly different from cytotoxic chemotherapies. It has been shown to inhibit and otherwise modify signaling through a number of pathways including Akt, p21, and JNK. Perifosine has been tested in Phase I and Phase II settings in a variety of dosing schedules including daily, weekly, and daily following a loading dose. In general, it has been well tolerated with dose-related nausea, vomiting, diarrhea, and fatigue being the most commonly observed toxicities. Perifosine has induced partial responses or stable disease in solid tumors including but not limited to renal cell, sarcoma, and hepatocellular carcinoma. Perifosine is currently being studied in multiple diseases as a single agent as well as in combination with other cancer therapies. As studies are closed there are patients that have achieved a partial response or stable disease.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by AEterna Zentaris.