Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-28 @ 5:45 AM
Study NCT ID:
NCT01169532
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2010-07-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
A Phase I Study of Ridaforolimus and Vorinostat in Patients With Advanced Solid Tumors or Lymphoma (IND 109130)
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2010-01907 | REGISTRY | CTRP (Clinical Trials Reporting System) | View |