This open label, dose escalation, Phase I study determines the maximum tolerated dose of LE-DT in patients with metastatic solid cancer who have failed conventional therapy. Up to five dose levels will be studied at up to three investigational sites.
NeoPharm anticipates the enrollment of 25 to 30 patients. The secondary objectives of this study will be to evaluate the pharmokinetics of docetaxel following intravenous administration of LE-DT.
Aquilur Rahman, chief scientific adviser of NeoPharm, said: “LE-DT is NeoPharm’s new modality of treatment to enter the clinic for Taxotere, a chemotherapeutic drug in wide use for the treatment of several forms of advanced cancers, including metastatic breast and ovarian.”