Brief Summary

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or capecitabine alone. The effects of perifosine may be manifested by increased time to progression, tumor regression reflected in partial or complete responses, or a combination of these outcomes. The primary goal of this trial is to obtain a preliminary and objective assessment of the effects of perifosine on time to progression.

Trial Health

On Track

Trial Health Score

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

Enrollment

381

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2005

Longer than P75 for phase_2

Geographic Reach

1 country

49 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

6.2 years study duration

Study Start

First participant enrolled

August 1, 2005

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2006

Completed

8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed

Last Updated

March 14, 2018

Status Verified

February 1, 2012

Enrollment Period

5.3 years

First QC Date

November 6, 2006

Last Update Submit

March 12, 2018

Conditions

Colon Cancer

Keywords

Capecitabine

Outcome Measures

Primary Outcomes (1)

Effects of perifosine on time to progression
Time to progression will be measured from the first day of study drug until progression.
Every 12 weeks

Secondary Outcomes (2)

Toxicity
Every 12 weeks
Comparison of time to progression to historical experience
Every 12 weeks

Study Arms (2)

Arm 1: Perifosine + Capecitabine

EXPERIMENTAL

Perifosine 50 mg/d qd + Capecitabine 825 mg/m\^2 BID days 1 - 14 q 3 weeks until progression

Drug: PerifosineDrug: Capecitabine

Arm 2: Perifosine Placebo + Capecitabine

PLACEBO COMPARATOR

Perifosine Placebo 50 mg/d qd + Capecitabine 825 mg/m\^2 BID days 1 - 14 q 3 weeks until progression

Drug: CapecitabineOther: Perifosine Placebo

Interventions

PerifosineDRUG

Perifosine 50 mg/d qd

Also known as: D-21266, KRX-0401

Arm 1: Perifosine + Capecitabine

CapecitabineDRUG

Capecitabine 825 mg/m\^2 BID days 1 - 14 q 3 weeks

Arm 1: Perifosine + CapecitabineArm 2: Perifosine Placebo + Capecitabine

Perifosine PlaceboOTHER

Placebo to Perifosine 50 mg/d qd

Also known as: placebo

Arm 2: Perifosine Placebo + Capecitabine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

In the opinion of the treating physician, treatment with one of the following regimens should represent an appropriate treatment for the patient.
\- Capecitabine 825 mg/m2 BID days 1 - 14 q 3 weeks
Patients should have a histologically or cytologically confirmed diagnosis of colorectal cancer.
Patients must have received at least one but no more than two prior chemotherapy regimen(s) for the treatment of metastatic or recurrent disease.
ECOG performance status 0 or 1.
Leukocytes \>= 4,000/μL
absolute neutrophil count \>= 1,500/ μL
platelets \>= 100,000/ μL
HCT \> 28% (with or without growth factor support)
Creatinine \<= 2.5 mg/dl
total bilirubin \< 1.5 x upper limit of normal
transaminase \< 2.5 x upper limit of normal
Patients must have recovered from acute toxicity-excluding alopecia-related to prior therapy, including surgery or radiotherapy.
Patients with brain metastases may be admitted, provided the disease has been treated and been stable for 2 months.
Patients must have ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

Patients receiving any other investigational agents or devices.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements.
HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study due to potential pharmacokinetic interactions with perifosine.
Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Assoc. class II - IV congestive heart failure.
Female patients who are pregnant or lactating are ineligible.

Contact the study team to confirm eligibility.