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Spots Global Cancer Trial Database for Phase 1 Study of Oral TP-1454

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We do not endorse or review these studies in any way.

Trial Identification

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

Interventions

TP-1454 monotherapy

Study Description

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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Jian Li, MD

Affiliation: Sumitomo Pharma America, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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