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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by AEterna Zentaris.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01224730
First received: October 19, 2010
Last updated: May 30, 2012
Last verified: May 2012

October 19, 2010
May 30, 2012
January 2012
May 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
  • 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)
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: 28 days ] [ Designated as safety issue: No ]
  • 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)
Complete list of historical versions of study NCT01224730 on ClinicalTrials.gov Archive Site
To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • 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.
To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
- To evaluate the safety profile (adverse events) and efficacy (response rate, and time to progression) of all study patients treated with perifosine
Not Provided
Not Provided
 
A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: perifosine
100 mg daily
Experimental: Perifosine 100 mg
Perifosine 100 mg orally daily under Fed and Fasted conditions
Intervention: Drug: perifosine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224730
Protocol 147
Yes
AEterna Zentaris
AEterna Zentaris
Not Provided
Study Director: Ed Cullen, PhD Keryx / AOI Pharmaceuticals, Inc.
AEterna Zentaris
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP