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

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ClinicalTrials.gov Identifier: NCT00847366
Recruitment Status : Unknown
Verified October 2011 by AEterna Zentaris.
Recruitment status was:  Active, not recruiting
First Posted : February 19, 2009
Last Update Posted : May 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is an open label trial for patients currently enrolled in other perifosine trials.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Solid Tumors Metastatic Breast Cancer Sarcomas Drug: Perifosine

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : May 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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
More Information

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00847366     History of Changes
Other Study ID Numbers: Perifosine 534
First Posted: February 19, 2009    Key Record Dates
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