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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00847366

Enrollment

Registered

2009-02-19

Start date

2008-05-31

Completion date

2012-12-31

Last updated

2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer, Non Small Cell Lung Cancer, Sarcomas, Solid Tumors

Keywords

Perifosine

Brief summary

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

Detailed 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.

Interventions

DRUGPerifosine

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

DRUGTrastuzumab

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

DRUGTamoxifen

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026