EntreMed Starts Phase I Continuous Dosing Trial of Cancer Drug
Posted on: Thursday, 3 April 2008, 09:01 CDT
EntreMed has initiated a Phase I, open-label, continuous dosing study with its oral cell cycle inhibitor, MKC-1, in patients with advanced or metastatic solid tumors.
The objective of the dose-escalation trial is to determine the maximum tolerated dose of MKC-1 administered orally twice a day continuously in advanced or refractory solid tumor patients. Response and tumor marker improvement will also be evaluated. Up to 24 patients with metastatic or unresectable solid tumors for which standard curative measures do not exist or are no longer effective will be enrolled.
Carolyn Sidor, EntreMed's vice president and chief medical officer, said: "We believe that a continuous dosing schedule has the potential to improve tolerability and enhance MKC-1 activity in cancer patients, similar to increased antitumor activity that sustained exposure has demonstrated in preclinical studies. Through this Phase I study, we expect to determine not only the maximum tolerated dose of MKC-1 when administered orally twice a day on a continuous basis, but also the pharmacodynamic changes using imaging techniques as proof of drug effect and assessment of toxicity."
Source: Datamonitor
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