NCT01224730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 24, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2013

Completed
Last Updated

March 14, 2018

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

October 19, 2010

Last Update Submit

March 12, 2018

Conditions

Cancer

Outcome Measures

Primary Outcomes (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

    * 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 Outcomes (1)

  • To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies

    Up to 6 months

Study Arms (1)

Perifosine 100 mg

EXPERIMENTAL

Perifosine 100 mg orally daily under Fed and Fasted conditions

Drug: perifosine

Interventions

perifosineDRUG

100 mg daily

Also known as: D-21266, KRX-0401
Perifosine 100 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced malignancies
  • Patients with adequate organ and marrow function

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Dallas, Texas, 75230, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

perifosine

Study Officials

  • Ed Cullen, PhD

    Keryx / AOI Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 20, 2010

Study Start

January 24, 2012

Primary Completion

November 4, 2013

Study Completion

November 4, 2013

Last Updated

March 14, 2018

Record last verified: 2012-05

Locations

US(2)