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A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT01224730
Recruitment Status : Unknown
Verified May 2012 by AEterna Zentaris.
Recruitment status was:  Active, not recruiting
First Posted : October 20, 2010
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris

Brief Summary:

This is a Phase I study which will analyze any food-drug effects as well as QTc effects of perifosine. Safety and efficacy will also be evaluated.

Patients who complete the first 24 days on single agent perifosine may have the opportunity to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine + perifosine; or 3) switch to the combination of sorafenib + perifosine.


Condition or disease Intervention/treatment Phase
Cancer Drug: perifosine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
Study Start Date : January 2012
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: Perifosine 100 mg
Perifosine 100 mg orally daily under Fed and Fasted conditions
Drug: perifosine
100 mg daily



Primary Outcome Measures :
  1. To evaluate the effects of food on the PK profile and bioavailability of perifosine, and to evaluate the effects of perifosine treatment on ECG parameters [ Time Frame: 24 days ]
    • To assess the Pharmacokinetic profile of perifosine when given to patients under fed and fasted conditions
    • To evaluate changes in other ECG parameters associated with perifosine treatment (ventricular rate, PR interval, QRS interval, QT interval)


Secondary Outcome Measures :
  1. To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies [ Time Frame: Up to 6 months ]
    • To evaluate the safety profile (adverse events) and efficacy (response rate, and time to progression) of all study patients treated with perifosine.
    • After Day 24, to evaluate the safety profile (adverse events) and efficacy (response rate and time to progression) of all study patients who remain on single agent perifosine, switch to the combination of capecitabine + perifosine or switch to the combination of sorafenib + perifosine.



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 with advanced malignancies
  • Patients with adequate organ and marrow function

Exclusion Criteria:

  • Patients previously treated with perifosine
  • Patients receiving any other chemotherapy, targeted agents, investigational agents or devices within four weeks (28 days) prior to Day 1 of study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224730


Locations
United States, Texas
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77030
Sponsors and Collaborators
AEterna Zentaris
Investigators
Study Director: Ed Cullen, PhD Keryx / AOI Pharmaceuticals, Inc.

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01224730     History of Changes
Other Study ID Numbers: Protocol 147
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012