An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
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
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
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety and tolerability of perifosine as a single agent as well as in combination with hormonal therapies or trastuzamab.
United States: Food and Drug Administration