Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma
|ClinicalTrials.gov Identifier: NCT01169532|
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : November 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Unspecified Adult Solid Tumor, Protocol Specific||Drug: ridaforolimus Drug: vorinostat Procedure: biopsy Other: pharmacological study Other: laboratory biomarker analysis||Phase 1|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Ridaforolimus and Vorinostat in Patients With Advanced Solid Tumors or Lymphoma (IND 109130)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: Treatment (ridaforolimus and vorinostat)
Patients receive ridaforolimus 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.
Other Names:Drug: vorinostat
Other Names:Procedure: biopsy
Optional correlative studies
Other Name: biopsiesOther: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
- Safety and tolerability of study treatment [ Time Frame: First 3 weeks of treatment ]Assessed by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 4.0.
- Progression free survival [ Time Frame: 1 year ]Kaplan Meier curves will be used. Proportions, 95% confidence intervals, and cumulative incidence curves will be used to characterize response rates.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169532
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Rockledge, Pennsylvania, United States, 19046|
|Principal Investigator:||Elizabeth Plimack||Fox Chase Cancer Center|