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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847366
• Other study ID #: Perifosine 534
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: March 12, 2018
• Start date: May 2008
• Est. completion date: December 2012

Study information

• Verified date: February 2018
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Metastatic Breast Cancer
• Multiple Myeloma
• Non Small Cell Lung Cancer
• Sarcomas
• Solid Tumors

Intervention

Drug:
• Perifosine
All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.
• Trastuzumab
Trastuzumab was given 6mg/kg i.v. daily or 2 mg/kg i.v. on day 1, 8 and 15.
• Tamoxifen
Endocrine therapy with tamoxifen will be evaluated in combination with perifosine to determine if the combination overcomes resistance to endocrine therapy .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AEterna Zentaris

Outcome

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