A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer

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.