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
  Purpose

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 Intervention Phase
Cancer
Drug: perifosine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 24
Study Start Date: January 2012
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perifosine 100 mg
Perifosine 100 mg orally daily under Fed and Fasted conditions
Drug: perifosine
100 mg daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01224730     History of Changes
Other Study ID Numbers: Protocol 147
Study First Received: October 19, 2010
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014