IDO Inhibitor Study for Relapsed or Refractory Solid Tumors (D-1MT)
This study provides an early evaluation of an entirely new class of small molecule agents directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be involved in the growth of many solid tumors.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Indoximod [1-methyl-D-tryptophan (D-1MT)] in Patients With Relapsed or Refractory Solid Tumors|
- Determine the safety and efficacy of administration of D-1MT into patients with recurrent or refractory solid tumors. Establish the toxicities of D-1MT and define any dose limiting toxicities if they occur below the maximum doses. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Preliminarily characterize effects of D-1MT on serum kynurenine levels as a biomarker for systemic IDO activity. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
D-1MT will be administered in escalating doses. Initial dosing will be 200 mg by mouth daily with escalation planned to 2000 mg by mouth daily and potentially higher doses in subsequent cohorts if tolerated and pharmacokinetic and biologic data support further dose escalation.
Other Name: D-1MT, NSC-721782, 1-MT
This protocol provides an early evaluation of an entirely new class of small molecule agents directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be involved in the growth of many solid tumors. D-1MT, or any other substance targeting this enzymatic pathway indoleamine-(2,3)-dioxygenase (IDO), has not been used previously in humans. Although pre-clinical toxicology in rats and dogs shows an extremely encouraging toxicity profile, the study needs to carefully evaluate the toxicities and pharmacokinetics to provide the basis for assigning a safe and biologically effective dosing regimen for later trials determining its contribution to tumor responses in phase II and III clinical trials.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739609
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Study Chair:||Charles J. Link, M.D.||NewLink Genetics Corporation|