Spots Global Cancer Trial Database for A Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate Cancer
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Trial Identification
Brief Title: A Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate Cancer
Official Title: A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of ASG-5ME Monotherapy in Subjects With Castration-Resistant Prostate Cancer (CRPC)
Study ID: NCT01228760
Conditions
Interventions
Study Description
Brief Summary: The purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD) and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate cancer (CRPC).
Detailed Description: The study has two components. The first aims to establish a safe dose of ASG-5ME. Once identified, the safety and preliminary estimate of antitumor activity of ASG-5ME will be tested in additional subjects with castration-resistant prostate cancer (CRPC) who are either chemotherapy naïve or chemotherapy exposed in expanded cohorts.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
The Karmanos Cancer Institute, Detriot, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Wisconsin Madison, Carbone Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Chief Medical Officer
Affiliation: Agensys, Inc.
Role: STUDY_DIRECTOR
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