Spots Global Cancer Trial Database for A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
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Trial Identification
Brief Title: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
Official Title: A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
Study ID: NCT01967043
Conditions
Interventions
Study Description
Brief Summary: This is a standard "3+3" Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181 Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Cancer Center, Aurora, Colorado, United States
Johns Hopkins University, Baltimore, Maryland, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Contact Details
Name: Min-Fun Rudolf Kwan, MD
Affiliation: Kinex Pharmaceuticals Inc.
Role: STUDY_DIRECTOR
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