Solid Tumors Clinical Trial
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
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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