BPI-7711 Capsule in Patients With EGFR Mutation T790M Positive Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title: An Open-label, Single Arm, Phase I/IIa Study to Evaluate Safety, Dose Escalation Tolerability, Pharmacokinetics and Antineoplastic Activity of the BPI-7711 Capsule in Patients With EGFR Mutation Advanced or Recurrent NSCLC

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This is a single arm, open label study, including phase I (a "dose escalation" part and a "dose extension" part) and phase IIa.

Dose escalation: on the basis of the traditional "3+3" dose escalation plan; single dose PK test is added. The subjects of each dose group will first be given a single dose, and blood samples be collected for PK analysis. 7 days (wash-out period) after single dose delivery, an additional 21 days of continuous multiple dose delivery will be given as a treatment cycle to evaluate the dose limiting toxicity (DLT). The initial dose will be 30 mg once a day. In the initial dose group, the second subject will be enrolled and administered with the study drug 7 days after the first dosing (single dose) to the first subject. If there is no occurrence of serious or unexplainable safety event, the subsequent following-up subjects will be enrolled and receive the dose. If suspected safety event occurs, the investigator will discuss with the sponsor whether to delay dose delivery to the following-up subjects of the said group.

Every dose escalation group will enroll 3 to 6 subjects. Dose adjustment will be based on the following scheme:

• If there is 0 case of DLT in 3 subjects of the initial dose group in the first treatment cycle, then the treatment dose of the subsequent 3 patients will be increased to level 2.

• If there is 1 case of DLT in 3 subjects of the initial dose group in the first treatment cycle, then additional 3 patients will be enrolled in the group and accept the level 1 dose treatment.

• If there is 0 case of DLT in the 3 new subjects, the dose will be increased to level 2.

• If there is ≥1 case of DLT in the 3 new subjects, the principal investigator and the sponsor will discuss to determine the next step dose scheme.

• If there are ≥2 cases of DLT in 3 subjects of the initial dose group, the principal investigator and the sponsor will meet to discuss the alternative dose delivery scheme.

The same dose escalation rules shall be applicable to the following dose groups. Based on available tolerance, safety, and PK data, recommended Phase II dose (RP2D) will be selected.

Dose extension group: If a certain dose is found to be safe and effective, dose expansion will be initiated and about 20-30 subjects will be enrolled into that dose level. There will be no DLT evaluation for subjects of the dose extension study. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT03386955
• Study type: Interventional
• Source: Beta Pharma, Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 16, 2017
• Completion date: December 23, 2021