Ignite Creation Date:
2024-05-06 @ 12:48 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01664000
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2012-08-02
Brief Title:
A Safety Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors
Sponsor:
Cellceutix Corporation
Organization:
Cellceutix Corporation
Study Overview
Official Title:
A Phase 1 Open-Label Dose-Escalation Safety Pharmacokinetic and Pharmacodynamic Study of Kevetrin Thioureidobutyronitrile Administered Intravenously in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-02
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:
In the laboratory Kevetrin activates p53 a tumor suppressor protein that has an important role in protecting the body p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers Research experiments showed that when cancer cells were treated with Kevetrin it activated p53 which induced p21 a protein that inhibits cancer cell growth p53 also induced PUMA p53 up-regulated modulator of apoptosis a protein that causes tumor cell death Because of these activities slowing cancer cell growth and causing cancer cell death Kevetrin may help to treat tumors
Detailed Description:
Kevetrin was found to be effective in pre-clinical studies of human xenograft tumor models and was reasonably well-tolerated at therapeutic doses in the non-clinical animal studies Kevetrin was also effective in multi-drug resistant tumor models therefore Kevetrin has the potential to treat tumors that have become resistant to standard chemotherapy This trial will determine tolerance in humans and possibly efficacy with a Phase I open-label dose-escalation safety pharmacokinetic and pharmacodynamic study of Kevetrin in adult patients with solid tumors
The primary objectives are the following
To determine the maximum tolerated dose MTD of Kevetrin
To determine the dose limiting toxicities DLT of Kevetrin
To establish a safe dose level of Kevetrin that can be used for future studies
The secondary objectives are to determine the following
The pharmacokinetics of Kevetrin in humans
Observe for evidence of antitumor activity following administration of Kevetrin
If Kevetrin induces changes in the biomarker p21 in peripheral blood lymphocytes
If there is a pharmacodynamic relationship between the plasma concentrations of Kevetrin and a clinical or cellular effect
During each 4 week cycle each patient will receive three weekly doses of Kevetrin given as a 1 hour intravenous infusion followed by a 1 week off-treatment period Following each dose each patient will be monitored If the patients have acceptable safety and tolerance Kevetrin will be given once weekly for a total of 3 weeks During each cycle patients will be evaluated for safety tolerance and Dose-Limiting Toxicity DLT that occur during a cycle
The primary objectives are the following
To determine the maximum tolerated dose MTD of Kevetrin
To determine the dose limiting toxicities DLT of Kevetrin
To establish a safe dose level of Kevetrin that can be used for future studies
The secondary objectives are to determine the following
The pharmacokinetics of Kevetrin in humans
Observe for evidence of antitumor activity following administration of Kevetrin
If Kevetrin induces changes in the biomarker p21 in peripheral blood lymphocytes
If there is a pharmacodynamic relationship between the plasma concentrations of Kevetrin and a clinical or cellular effect
During each 4 week cycle each patient will receive three weekly doses of Kevetrin given as a 1 hour intravenous infusion followed by a 1 week off-treatment period Following each dose each patient will be monitored If the patients have acceptable safety and tolerance Kevetrin will be given once weekly for a total of 3 weeks During each cycle patients will be evaluated for safety tolerance and Dose-Limiting Toxicity DLT that occur during a cycle
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-151 | OTHER | Dana-Farber Cancer Institute | None |