Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
This trial is active, not recruiting.
|Conditions||non small cell lung cancer, solid tumors, metastatic breast cancer, sarcomas|
|Targets||JNK1, AKT, NF-kB|
|Start date||May 2008|
|End date||December 2012|
|Trial size||50 participants|
|Trial identifier||NCT00847366, Perifosine 534|
This is an open label trial for patients currently enrolled in other perifosine trials.
|Endpoint classification||safety study|
|Intervention model||crossover assignment|
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
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
|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.|
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