NCT01169532

Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma

A Phase I Study of Ridaforolimus and Vorinostat in Patients With Advanced Solid Tumors or Lymphoma (IND 109130)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	ridaforolimus	Given PO
DRUG	vorinostat	Given PO
PROCEDURE	biopsy	Optional correlative studies
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-07-26
• Last updated: 2021-02-21
• Results posted: 2021-02-21

Locations

1 site across 1 country: United States