BPI-7711 Capsule in Patients With EGFR Mutation T790M Positive Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed 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.
    

Intervention name(s): BPI-7711 Capsule
Intervention type(s): Drug
Intervention description(s): Phase I: BPI-7711 capsule(30mg, 60mg, 120mg, 180mg, 240mg...) Phase IIa: BPI-7711 capsule(with recommend phase II dose)
Other intervention name(s): BPI-7711; BPI7711 Capsule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-small cell lung cancer; NSCLC