Spots Global Cancer Trial Database for PEN-866 in Patients With Advanced Solid Malignancies
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Trial Identification
Brief Title: PEN-866 in Patients With Advanced Solid Malignancies
Official Title: A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies
Study ID: NCT03221400
Conditions
Study Description
Brief Summary: Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
Detailed Description: Phase 1a will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD) of PEN-866 (single agent). Phase 1b will employ a standard 3 + 3 design to make dose recommendations and estimate the MTD of PEN-866 in combination therapy. Phase 2a (single agent) will assess the safety, tolerability, pharmacokinetic, and pharmacodynamics profile of PEN-866 (single agent) at the recommended Phase 2 dose determined at the conclusion of Phase 1a in patients with advanced solid malignancies.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group, Springdale, Arkansas, United States
Sarah Cannon Reasearch Institute at HealthONE, Denver, Colorado, United States
Florida Cancer Specialists - South, Fort Myers, Florida, United States
Florida Cancer Specialists - North, Saint Petersburg, Florida, United States
Florida Cancer Specialists - East, West Palm Beach, Florida, United States
National Institutes of Health / National Cancer Institute, Bethesda, Maryland, United States
Henry Ford, Detroit, Michigan, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Stephenson Cancer Center, University of Oklahoma, Oklahoma City, Oklahoma, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Prisma Health - Upstate, Greenville, South Carolina, United States
The West Clinic, Germantown, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Anish Thomas, MD
Affiliation: National Cancer Institute (NCI)
Role: STUDY_CHAIR
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