Spots Global Cancer Trial Database for A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts
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Trial Identification
Brief Title: A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts
Official Title: A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts
Study ID: NCT02266745
Interventions
Study Description
Brief Summary: This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase is complete and no longer enrolling. The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).
Detailed Description: This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase, and the Dose Expansion Phase The Dose Escalation Phase and the Dose Expansion Thymoma Cohort are complete and no longer enrolling. The Dose Expansion Phase of the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) is open and enrolling.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Arizona, Phoenix, Arizona, United States
Tucson, Tucson, Arizona, United States
Duarte, Duarte, California, United States
Colorado, Aurora, Colorado, United States
Jacksonville, Jacksonville, Florida, United States
Orlando, Orlando, Florida, United States
Indianapolis, Indianapolis, Indiana, United States
Boston, Boston, Massachusetts, United States
Minneapolis, Minneapolis, Minnesota, United States
Rochester, Rochester, Minnesota, United States
Omaha, Omaha, Nebraska, United States
Albuquerque, Albuquerque, New Mexico, United States
Brooklyn, Brooklyn, New York, United States
New York, New York, New York, United States
Durham, Durham, North Carolina, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Seattle, Seattle, Washington, United States
Besançon, Besançon, , France
Bordeaux, Bordeaux, , France
Caen, Caen, , France
Clermont-Ferrand, Clermont-Ferrand, , France
Marseille, Marseille, , France
Nice, Nice, , France
Paris, Paris, , France
Rennes, Rennes, , France
Contact Details
Name: Daniel D. Karp, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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