BPI-7711 Capsule in Patients With EGFR Mutation T790M Positive Non-small Cell Lung Cancer
Active, not recruiting
Beta Pharma Shanghai
Phase 1/Phase 2
Lung cancer has the highest incidence rate in China and is also a very common cancer in the
world. BPI-7711 is a new drug developed for patients with non-small cell lung cancer.
The purpose of this study is to evaluate the safety, efficacy and PK profile of BPI-7711. The
first part of the study will recruit 3~6 patients for different dose levels to evaluate
safety. The dose will increase from the lowest level. The second part of the study is the
dose expansion. Once efficacy is observed in the dose increasing process, additional 20~30
patients will be enrolled to further evaluate the anti-tumor efficacy. A recommended dose
will be selected for Phase II study.
A Phase IIb Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients With T790M Mutation Positive
Active, not recruiting
Beta Pharma, Inc.
Phase 2
A phase IIb, open-label, single-arm study to assess the safety and efficacy of BPI-7711
capsule in patients with metastatic or recurrent non-small cell lung cancer with EGFR
mutation and T790M mutation positive.
A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
Recruiting
Beta Pharma, Inc.
Phase 3
A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and
safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve
non-small cell lung cancer patients with EGFR mutation
A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711
Completed
Beta Pharma, Inc.
Phase 1
This is an open-label, randomised, single-dose, cross-over phase I study to evaluate the
effect of food on the pharmacokinetic profile of BPI-7711 in Chinese healthy male subjects.
A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711
Completed
Beta Pharma, Inc.
Phase 1
This is a phase I study to assess the effect of itraconazole and rifampicin on the
pharmacokinetic parameters of BPI-7711 in Chinese healthy volunteers.
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