Phase 1 Trials at Dana Farber and Beth Israel Deaconess/Harvard Cancer Centers
The Phase 1 trials for solid tumors are at Harvard Cancer Center’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center.
The trial, titled, “A Phase I, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (thioureidobutyronitrile) Administered Intravenously in Patients with Advanced Solid Tumors,” will be conducted for the determination of the pharmacokinetics, pharmacodynamics, tolerance, safety, and maximum tolerated dose in patients with the diagnosis of refractory solid tumors. Approximately 40 patients will be enrolled in the dose escalation portion of study. In addition, once the MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level to further evaluate this dosage safety and pharmacodynamics.
The Principal Investigator for the trial is Geoffrey Shapiro, MD, PhD, Director, Early Drug Development Center and Associate Professor of Medicine, Harvard Medical School.
The primary objectives are:
- 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 there is a pharmacodynamic relationship between the plasma concentrations of Kevetrin and a clinical/cellular effect.
- If Kevetrin induces changes in the biomarker p21 in peripheral blood lymphocytes.