Spots Global Cancer Trial Database for A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors
Official Title: A Phase I Open-Label, Multiple Dose, Sequential Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced and Refractory Solid Tumors
Study ID: NCT00728793
Conditions
Interventions
Study Description
Brief Summary: This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Karmanos Cancer Institute, Detroit, Michigan, United States
START (South Texas Accelerated Research Therapeutics), San Antonio, Texas, United States
Contact Details
Name: Anthony Tolcher, M.D.
Affiliation: START (South Texas Accelerated Research Therapeutics)
Role: PRINCIPAL_INVESTIGATOR
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