The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Phase I Study of BPI-16350 in Patients With Advanced Solid Tumor
Official Title: A Phase I Study of BPI-16350 in Patients With Advanced Solid Tumor
Study ID: NCT03791112
Brief Summary: This was an open-label Phase I study. The primary objective of the study was to assess safety, tolerability, efficacy, and pharmacokinetic characteristics of BPI-16350 in different dose groups.
Detailed Description: The study was divided into two sections: dose escalation section and expanded enrollment section. In dose escalation section, BPI-16350 were administered orally once daily (QD) to patients with locally advanced or metastatic solid tumors in different dose levels.The study was designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and multiple doses of BPI-16350. In expanded enrollment section, based on the results of dose escalation section, BPI-16350 were administered orally to patients with locally advanced or metastatic solid tumors, to further evaluate the safety, tolerability, and pharmacokinetics of BPI-16350.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Betta Pharmaceuticals Co., Hangzhou, Zhejiang Provice, China