A Phase I Study of Ridaforolimus and Vorinostat in Patients With Advanced Solid Tumors or Lymphoma (IND 109130)
PRIMARY OBJECTIVES:
I. To determine which dose combinations of Ridaforolimus and Vorinostat are safe and
tolerable.
II. To define the maximum tolerated dose. III. To characterize dose limiting toxicities.
SECONDARY OBJECTIVES:
I. To describe the activity of this combination amongst all enrolled patients in terms of
response rate, progression free survival and overall survival.
II. To describe the activity of this combination in the subset of patients with RCC in terms
of response rate, progression free survival and overall survival.
III. To describe the pharmacodynamic effects of these agents in combination.
OUTLINE: This is a dose escalation study.
Patients receive ridaforolimus orally (PO) once daily on days 1-5 and vorinostat PO twice
daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every three months for up to 3
years.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of study treatment
Assessed by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 4.0.
First 3 weeks of treatment
Yes
Elizabeth Plimack
Principal Investigator
Fox Chase Cancer Center
United States: Food and Drug Administration
NCI-2010-01907
NCT01169532
October 2010
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |