drugset
drugset / Trial / NCT03791112

A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor

NCT03791112 ↗

Phase 1 Active not recruiting 54 enrolled Betta Pharmaceuticals Co., Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-07-18
Primary completion
2025-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject tibremciclib Small molecule 50 mg Oral
Subject tibremciclib Small molecule 100 mg Oral
Subject tibremciclib Small molecule 200 mg Oral
Subject tibremciclib Small molecule 300 mg Oral
Subject tibremciclib Small molecule 400 mg Oral
Subject tibremciclib Small molecule 500 mg Oral

Indications

cancer