Last updated on February 2018

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

Brief description of study

Lung cancer has the highest incidence rate in China and is also a very common cancer in the world. BPI-7711 is a potential new drug developed for advanced or recurrent non-small cell lung cancer.

The purpose of this study is to evaluate the safety, efficacy and how the drug is used by the body. 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. In the first part, the study will also collect data on how the drug is used by the body to better decide how the drug should be taken. The second part of the study is the expansion part. Once efficacy is observed in the dose increasing process, additional 20~30 patients will be enrolled to further evaluate the anti-tumor efficacy of each dose level. Estimate 50~80 patients will be enrolled for both part. A recommended dose will be selected for Phase II study.

Detailed Study Description

This is an open label, single arm Phase I study, including a "dose escalation" part and a "dose extension" part. Dose extension will be initiated during the process of dose escalation: once a dose is found to be safe and effective (evaluated according to objective response rate [ORR]) during escalation, then that dose will be extended to enroll more patients; at the same time, dose escalation will further continue in order to find out a better dose.

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, in the dose escalation group, it is found that certain dose is safe and effective, then dose expansion will be initiated and about 20-30 additional subjects will be enrolled into this dose level and treated with 21 days as a cycle. The said dose extension group will be ended in advance (less than 30 subjects) if efficacy found to be unsatisfying after discussed by the investigator and the sponsor. There will be no DLT evaluation for subjects of the dose extension study.

Clinical Study Identifier: NCT03386955

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Recruitment Status: Open

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