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Spots Global Cancer Trial Database for A Phase I Study of BPI-16350 in Patients With Advanced Solid Tumor

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Trial Identification

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

Interventions

BPI-16350

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Betta Pharmaceuticals Co., Hangzhou, Zhejiang Provice, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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