PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA
I. To estimate the clinical response rate in patients with metastatic malignant melanoma
treated with R115777 (tipifarnib).
II. To evaluate the safety of R115777 in patients with metastatic melanoma.
I. To assess RhoC expression in tumor samples pre- and post- therapy with R115777.
II. To evaluate Ftase levels in peripheral blood and tumor samples pre- and post-therapy
III. To assess the effect of R115777 treatment on T lymphocyte cytokine production, pre- and
post- therapy with R115777.
IV. Estimate time to treatment failure (TTF). Time to treatment failure is defined as time
to withdrawal for unacceptable toxicity or progressive disease.
OUTLINE Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every
28 days for at least 2 courses and for a maximum of 2 years in the absence of disease
progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2
additional courses beyond CR.
Patients who discontinue therapy due to toxicity or complete response are followed every 3
months for 2 years after study entry. Patients who discontinue therapy due to disease
progression are followed every 6 months for 2 years after study entry. Patients with stable
or partially responding disease who complete treatment are followed at 2 years after study
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response [CR] and partial response [PR]}
Estimated confidence intervals will be adjusted for the number of stages.
Up to 2 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
|Cancer and Leukemia Group B||Chicago, Illinois 60606|