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Brief Title: Phase 1 Study of Oral TP-1454
Official Title: A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 1454
Study ID: NCT04328740
Brief Summary: This study will evaluate the safety and tolerability of oral TP-1454 in patients with advanced metastatic or progressive solid tumors and anal cancer.
Detailed Description: Primary Objective: • To establish the MTD and/or Recommended Phase 2 Dose (RP2D) of orally administered TP-1454 in patients with metastatic solid tumors and anal cancer. Secondary Objectives: * To establish the pharmacokinetic (PK) profile of orally administered TP-1454 * To observe patients for any evidence of antitumor activity of TP 1454 by objective radiographic assessment * To assess the safety and tolerability of TP-1454
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Arizona, Phoenix, Arizona, United States
University of Southern California - Norris Cancer Center and Hoag Memorial Hospital, Los Angeles, California, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Comprehensive Cancer Center of Nevada, Las Vegas, Nevada, United States
Vanderbilt University, Nashville, Tennessee, United States
Texas Oncology Baylor Sammons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Jian Li, MD
Affiliation: Sumitomo Pharma America, Inc.
Role: STUDY_DIRECTOR