Status:
COMPLETED
A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer
Lead Sponsor:
AEterna Zentaris
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 wit...
Detailed Description
The primary purpose of Part I of this study was to determine the maximum dose of perifosine that can be administered with tolerable gastrointestinal toxicity; and to obtain preliminary information on ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00399789
Start Date
September 1 2004
End Date
December 1 2011
Last Update
February 22 2018
Active Locations (21)
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1
AOI Pharmaceuticals Investigative Site
Tucson, Arizona, United States, 85704
2
AOI Pharmaceuticals Investigative Site
Pomona, California, United States, 91767
3
AOI Pharmaceuticals Investigative Site
Aventura, Florida, United States, 33180
4
AOI Pharmaceuticals Investigative Site
Hollywood, Florida, United States, 33021