An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
18 Years
N/A
Both
Non Small Cell Lung Cancer, Solid Tumors, Metastatic Breast Cancer, Sarcomas
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the safety and tolerability of perifosine as a single agent as well as in combination with hormonal therapies or trastuzamab.
Outcome Time Frame:
12 weeks
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
Perifosine 534
NCT ID:
NCT00847366
Start Date:
May 2008
Completion Date:
December 2012
Related Keywords:
- Non Small Cell Lung Cancer
- Solid Tumors
- Metastatic Breast Cancer
- Sarcomas
- Perifosine
- Breast Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasms
- Sarcoma
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