NCT00739609

IDO Inhibitor Study for Relapsed or Refractory Solid Tumors

A Phase I Study of Indoximod [1-methyl-D-tryptophan (D-1MT)] in Patients With Relapsed or Refractory Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: NewLink Genetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Lung Cancer
• Melanoma
• Pancreatic Cancer
• Solid Tumors

Interventions

Type	Name	Description
DRUG	1-methyl-D-tryptophan	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.

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-08-22
• Last updated: 2020-05-28

Locations

1 site across 1 country: United States