Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors

PHASE1UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

May 31, 2021

Study Completion Date

June 30, 2021

Conditions
Breast CancerGastric CancerSolid TumorsNSCLC
Interventions
DRUG

Pyrotinib

Pyrotinib maleate, is provided as yellow, film-coated, immediate release tablets containing pyrotinib maleate at dosage strengths of 80 and 160 mg. Multiple tablets of pyrotinib will be administered daily to achieve targeted doses of pyrotinib: 320 mg, 400 mg, 480 mg, 560 mg and 640 mg. Tablets will be orally administered with water, once daily, 30 min after a meal.

Trial Locations (10)

10065

Memorial Sloan Kettering Cancer Center, New York

34232

Florida Cancer Specialists, Sarasota

37203

Tennessee Oncology, Nashville

48202

Henry Ford Health System, Detroit

63110

Washington University, St Louis

78229

South Texas Accelerated Research Therapeutics, San Antonio

92868

University of California, Irvine School of Medicine, Orange

95817

UC Davis Comprehensive Cancer Center, Sacramento

02114

Massachusetts General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

Sponsors
All Listed Sponsors
lead

Hengrui Therapeutics, Inc.

INDUSTRY