Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT01169532
Brief Summary:
This phase I trial is studying the side effects and best dose of giving ridaforolimus and vorinostat together in treating patients with advanced solid tumors or lymphoma. Giving ridaforolimus in combination with vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
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.
Study:
NCT01169532
Study Brief:
Protocol Section:
NCT01169532