Open Label Trial of Perifosine in Patie… | Clinical Trial

Key information

Conditions

Non Small Cell Lung Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Metastatic Breast Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Sarcomas Skin Diseases Skin and Connective Tissue Diseases Solid Tumors Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Regarding the protocol no exclusion criteria are described.

Treatment and study plan

Perifosine

Drug

All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.

Other names: D-21266, KRX-0401

Trastuzumab

Drug

Trastuzumab was given 6mg/kg i.v. daily or 2 mg/kg i.v. on day 1, 8 and 15.

Tamoxifen

Drug

Endocrine therapy with tamoxifen will be evaluated in combination with perifosine to determine if the combination overcomes resistance to endocrine therapy .

Primary outcomes

To evaluate the safety and tolerability

Time frame: 12 weeks

To evaluate the safety and tolerability of perifosine as a single agent as well as in combination with hormonal therapies or trastuzumab.

Sponsors and collaborators

Lead sponsor

AEterna Zentaris

Industry

Registry information

Official study title

An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Feb 19, 2009
Registry last updated: Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting