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

March 12, 2018 updated by: AEterna Zentaris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Exclusion Criteria:

  1. Patients with prior exposure to perifosine.
  2. Patients receiving any other chemotherapy, targeted agents, investigational agents or devices within four weeks (28 days) or 5 half-lives of the agent(s), whichever is longer, prior to Day1 of study treatment.
  3. Patients must have finished radiotherapy 28 days prior to start of treatment. Radiotherapy is not permitted in the Treatment Phase. Palliative radiotherapy to single sites for symptom control is allowed only during the Continuation Phase. The clinical coordinator should be contacted prior to initiating radiotherapy in this setting.
  4. Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks prior to Day 1 of study treatment.
  5. Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
  6. Patients with known central nervous system (CNS) metastases. Patients with CNS metastases that have been treated and are stable and who do not require corticosteroid treatment for the metastases (off steroids > 4 weeks) will be allowed.
  7. Serious active infection requiring parenteral antibiotics or antifungal therapy.
  8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  9. Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU (for patients electing to receive capecitabine therapy in the Continuation Phase).
  10. Patients with known HIV or acute or chronic active Hepatitis B or Hepatitis C.
  11. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would Limit compliance with study requirements.
  12. Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Association class II-IV congestive heart failure (Appendix B).
  13. Female patients who are pregnant or lactating. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Women of childbearing potential and men with partners of child-bearing potential, must agree to employ adequate contraception to prevent pregnancy while on therapy and for 4 weeks after the completion of treatment (see Appendix C).
  14. A history of additional risk factors for Torsades de Pointes (e.g. familial long QT syndrome, hypokalemia, heart failure (Appendix B), left ventricular hypertrophy, slow heart rate (<45 bpm)).
  15. Required use of concomitant medications known to prolong the QT/QTc interval

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75230
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Perifosine 100 mg
Perifosine 100 mg orally daily under Fed and Fasted conditions
Drug: perifosine
100 mg daily
Other Names:
  • D-21266
  • KRX-0401

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
24 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AEterna Zentaris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ed Cullen, PhD, Keryx / AOI Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Protocol 147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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