Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
NewLink Genetics Corporation |
---|---|
Information provided by: | NewLink Genetics Corporation |
ClinicalTrials.gov Identifier: | NCT00739609 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Lung Cancer Melanoma Pancreatic Cancer Solid Tumors |
Drug: 1-methyl-D-tryptophan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of 1-Methyl-D-Tryptophan (D-1MT) in Patients With Relapsed or Refractory Solid Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Cancer Information Program 800-811-8480 cip@vanderbilt.edu | |
Principal Investigator: Jeffrey Sosman, M.D. |
Study Chair: | Charles J. Link, M.D. | NewLink Genetics Corporation |
Responsible Party: | NewLink Genetics Corporation ( Charles J. Link, Jr., M.D. ) |
Study ID Numbers: | NLG2100 |
Study First Received: | August 20, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00739609 |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Tryptophan Digestive System Neoplasms Skin Diseases Pancreatic Neoplasms Endocrine System Diseases Breast Neoplasms Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Digestive System Diseases Respiratory Tract Diseases |
Lung Neoplasms Nevus, Pigmented Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Nevus Breast Diseases Endocrine Gland Neoplasms |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Therapeutic Uses Neoplasms, Nerve Tissue |
Psychotropic Drugs Nevi and Melanomas Antidepressive Agents, Second-Generation Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |