Brief Summary

This is a study of the drug perifosine that consists of 2 parts. The first part of this study was designed to determine the highest dose of perifosine that can be administered to people every week without severe or prolonged nausea, vomiting and diarrhea. This study started with patients taking 900 mg/week and went up to 1800 mg/week. Part I of this study is completed. The MTD had been determined and incorporated in Part II. The goals in Part II are to:

1.Compare the gastrointestinal toxicity of 3 different dose-schedules and
2.Obtain preliminary information on the response rate of perifosine in non-small cell lung cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

121

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Sep 2004

Longer than P75 for phase_1

Geographic Reach

1 country

21 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

7.3 years study duration

Study Start

First participant enrolled

September 1, 2004

Completed

2.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed

Last Updated

February 22, 2018

Status Verified

February 1, 2012

Enrollment Period

6.3 years

First QC Date

November 13, 2006

Last Update Submit

February 20, 2018

Conditions

Non Small Cell Lung Cancer

Keywords

Non-Small-Cell LungPerifosine

Outcome Measures

Primary Outcomes (1)

Gastrointestinal toxicity of 3 different dose-schedules
The frequency of grade 2 or greater gastrointestinal toxicities between the 3 arms of the study will be observed and used to determine the best regimen
12 weeks

Secondary Outcomes (1)

Preliminary information on response rate
3 months

Study Arms (3)

Perifosine 150 mg qd

ACTIVE COMPARATOR

A daily dose of 150 mg to be given in one dose at bedtime. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 200 mg to be given in one dose at bedtime.

Drug: Perifosine

Perifosine 900 mg per week

ACTIVE COMPARATOR

A weekly dose of 900 mg to be divided into three doses of 300 mg each. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 1,200 mg divided into four doses of 300 mg.

Drug: Perifosine

Perifosine 50 mg tid

ACTIVE COMPARATOR

A daily dose of 150 mg to be divided into three doses of 50 mg each. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 200 mg divided into four doses of 50 mg.

Drug: Perifosine

Interventions

PerifosineDRUG

Perifosine will be tested in 3 dose forms

Perifosine 150 mg qdPerifosine 50 mg tidPerifosine 900 mg per week

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer, must have progressed despite standard therapy and must not be candidates for surgical or combined modality therapy.
At least 18 years of age.
Patients should have received at least one but no more than two prior chemotherapy regimens for metastatic disease. The study chairman or medical monitor will consider extenuating circumstances for patients with more than two such regimens.
Patients must have measurable disease. Since the outcome for a patient is to be based on response using RECIST criteria, the patient must have at least one measurable lesion that can be accurately measured in at least one dimension and fit one of the following criteria: longest diameter 20 mm using conventional techniques or 10 mm with spiral CT scan.
Patients must have a life expectancy of more than 3 months.
Patients should have a performance status of 0 to 1 according to the ECOG criteria. However, patients with ECOG performance status of 2 may be admitted with approval from the study chairman or medical monitor.
Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy and for four weeks after the completion of treatment.
Patients must have ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

Patients with rapidly progressing disease, as defined by progression within 12 weeks of initiation of the previous regimen.
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 and psychiatric illness/social situations that would limit compliance with study requirements.
HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible 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.

Contact the study team to confirm eligibility.