Study of Intravenous TCD-717 in Patients With Advanced Solid Tumors

Status Completed

Clinical Trial Summary

This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of this study are to evaluate the safety of the drug and to determine the maximum tolerated dose and appropriate dose for phase II studies. Secondary objectives are to measure the efficacy of TCD-717; and in a substudy to be conducted in the MTD confirmation cohort only, to evaluate the potential correlation between the levels of tumor choline and tumor response to the choline kinase alpha inhibitor, TCD-717, using magnetic resonance spectroscopy. Pharmacokinetics analysis will be performed on patients enrolled in the maximum tolerated dose confirmation cohort.

Clinical Trial Description

TCD Pharma has developed TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha (ChoKα), involved in the synthesis of phosphatidylcholine, which constitutes the major phospholipid in eukaryotic cell membranes and has been described as a potent oncogen when overexpressed in human cells. TCD-717 will be evaluated in this Phase I, open-label, single arm study to be performed at multiple centers. TCD-717 will be administered as a 4 hour infusion on two separate days per 7-day period per 28-day cycle (8 administrations per cycle). Eligible patients must have confirmed, metastatic or recurrent/refractory solid tumors. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Advanced Solid Tumors

Clinical Trial Details

NCT number	NCT01215864
Study type	Interventional
Source	Traslational Cancer Drugs Pharma, SL
Contact
Status	Completed
Phase	Phase 1
Start date	January 2011
Completion date	February 2014

View Details

See also
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