According to the primary outcomes of the study, Phase 1 is already a success and future trials assuredly will follow. The only question is whether or not the secondary outcomes will demonstrate more positive or highly positive results.
Title: "A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors"
Primary outcomes: A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety.
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 MTD has already exceeded 100 mg/m^2, the expected range for efficacy, and beyond the minimum range rationalizing future studies.
Secondary outcomes included in the title: Pharmacokinetic Profile of Kevetrin;
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.
At this point in the trial, they have sufficient samples for a complete PK profile, sufficient evidence of antitumor activity confirmed in public documentss, changes in p21 at lower doses confirmed in public documents, and sufficient samples for cellular effect up to blood plasma concentrations at 110 mg/kg.
All that spells minimal success in Phase 1 that assures future studies in combination trials.
They serve beer Popsicles?
