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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by AEterna Zentaris.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847366
First Posted: February 19, 2009
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AEterna Zentaris
  Purpose
This is an open label trial for patients currently enrolled in other perifosine trials.

Condition Intervention
Non Small Cell Lung Cancer Solid Tumors Metastatic Breast Cancer Sarcomas Drug: Perifosine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Perifosine 201: A Phase 1/2 trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer
Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression.
Experimental: 2
Perifosine 206: A Randomized Phase II Trial of Three Doses of Perifosine in Combination With Trastuzumab
Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression
Experimental: 3
Perifosine 207: A Phase IIA Trial of Two Schedules of Perifosine
Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression
Experimental: 4
Perifosine 208: A Phase II Trial of Two Schedules of Perifosine in Combination with Endocrine Therapy for Patients with Estrogen Receptor or Progesterone Receptor Positive Metastatic Breast Cancer
Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression
Experimental: 5
Perifosine 209: A Phase II Trial of Perifosine in Patients with Sarcomas
Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00847366     History of Changes
Other Study ID Numbers: Perifosine 534
First Submitted: February 17, 2009
First Posted: February 19, 2009
Last Update Posted: May 30, 2012
Last Verified: October 2011

Keywords provided by AEterna Zentaris:
Perifosine

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Multiple Myeloma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases