Clinical Trials /

Safety, Tolerability and Pharmacokinetic Profile of BPI-15086 in EGFR T790M Mutation-positive NSCLC Patients



The main objective of this study is to evaluate the safety and tolerability of BPI-15086.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:



Phase 1

Trial Eligibility



  • Brief Title: Safety, Tolerability and Pharmacokinetic Profile of BPI-15086 in EGFR T790M Mutation-positive NSCLC Patients
  • Official Title: A Phase 1 Study of BPI-15086 in Patients With Epidermal Growth Factor Receptor T790M Mutation-positive Non-Small Cell Lung Cancer Who Have Progressed on Previous EGFR Tyrosine Kinase Inhibitor Therapy

Clinical Trial IDs

  • ORG STUDY ID: BTP-26511
  • NCT ID: NCT02914990


  • Non-Small Cell Lung Cancer




The main objective of this study is to evaluate the safety and tolerability of BPI-15086.

Detailed Description

      The main objective of this study is to evaluate the safety and tolerability of BPI-15086. In
      addition, the anti-cancer effect of BPI-15086 in EGFR T790M mutation-positive advanced NSCLC
      patients who have progressed on a previous EGFR tyrosine kinase inhibitor therapy will also
      be evaluated. Biomarkers related to the efficacy of BPI-15086 will be investigated.

Trial Arms

BPI-15086ExperimentalBPI-15086, orally administered daily
  • BPI-15086

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed, locally advanced or metastatic NSCLC
             patients, who is not suitable for surgery or radiotherapy

          -  Radiological documentation of disease progression while on a previous continuous EGFR
             TKI (e.g. icotinib, gefitinib, afatinib, neratinib, dacomitnib, or erlotinib)

          -  Patients must fulfil one of the following:

               -  Confirmation that the tumour harbours EGFR sensitivity mutation (exon 19
                  deletion, L858R and L861R, G719X)

               -  Must have experienced clinical benefit from EGFR TKIs, according to the Jackman

          -  Confirmation of T790M mutation positive after disease progression on EGFR TKIs

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and estimated life
             expectancy of at least 12 weeks

          -  Measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST1.1)

          -  Adequate bone marrow, hepatic, and renal function

          -  Women: For pre-menopausal women who have a childbearing potential, they must have a
             pregnancy test within 7 days before starting treatment. The serum or urine pregnancy
             test must be negative and must be non-lacking; all patients (whether male or female)
             should be Adequate barrier contraceptive measures during the entire treatment period
             and 3 months after the end of treatment

          -  Have signed Informed Consent Form

        Exclusion Criteria:

          -  Any other malignancy within 5 years of the first dose of study treatment

          -  Radiotherapy for target lesion within 4 weeks of the first dose of study treatment.

          -  From the treatment of reversible EGFR TKI drugs (e.g. Ectinib, Gefitinib, Erlotinib)
             to the first use of drugs, the time did not exceed 8 days or 5 half-lives (take the
             long time);Irreversible EGFR TKI drugs (e.g. Alfatinib, Neratinib, Dacomitinib) did
             not last more than 14 days or 5 half-lives (take the long term)

          -  Investigational agents or anticancer drugs (Including cytotoxic chemotherapy) from a
             previous treatment regimen or clinical study within 14 days of the first dose of study

          -  Prior treatment with other third generation EGFR TKIs, including osimertinib,
             rociletinib, EGF816, olmutinib, ASP8273 and avitinib

          -  Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for
             at least 4 weeks prior to start of study treatment

          -  History of interstitial lung disease, drug-induced interstitial lung disease,
             radiation pneumonitis which required steroid treatment, or any evidence of clinically
             active interstitial lung disease, radiological documentation of idiopathic pulmonary
             fibrosis at baseline; uncontrolled pleural effusion/pericardial effusion

          -  Any evidence of severe or uncontrolled systemic diseases, including CTCAE 2 or higher
             active infection, uncontrolled hypertension, unstable angina pectoris, congestive
             cardiac failure and severe liver/renal or metabolic disease

          -  Active infection including hepatitis B, hepatitis C and human immunodeficiency virus

          -  History of organ transplant; had surgery or severe injury within 4 weeks

          -  Any clinically important abnormalities in rhythm, conduction or morphology of resting
             ECG eg, complete left bundle branch block, third degree heart block, second degree
             heart block, PR interval >240msec, or QRS> 110 msec

          -  Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
             such as heart failure, hypokalaemia, congenital long QT syndrome, family history of
             long QT syndrome or unexplained sudden death under 40 years of age in first degree
             relatives or any concomitant medication known to prolong the QT interval

          -  Poorly controlled hyperglycemia(fasting blood glucose level ≥7.0 mmol/L).

          -  Any unresolved toxicities from prior therapy greater than Common Terminology Criteria
             for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the
             exception of alopecia

          -  Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
             swallow the formulated product or previous significant bowel resection that would
             preclude adequate absorption of BPI-15086

          -  It is known that the study drug or any of its excipients (microcrystalline cellulose,
             lactose, crospovidone, hydroxypropyl cellulose, magnesium stearate) are severely

          -  CYP3A4 strong inhibitors or inducers or Chinese herbal medicine for anti-tumor
             indications were used within 1 week before the first dose

          -  Abuse of drugs and medical, psychological or social conditions in patients may
             interfere with participating in the study or assessment of the results of the study

          -  Any condition that is unstable or may compromise patient safety and compliance with
             the study

          -  Researchers believe that patients who are not suitable for treatment with this regimen
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events
Time Frame:18 months
Safety Issue:
Description:Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03

Secondary Outcome Measures

Time Frame:4 weeks
Safety Issue:
Measure:Half life
Time Frame:4 weeks
Safety Issue:
Time Frame:4 weeks
Safety Issue:
Measure:Objective Response Rate
Time Frame:12 weeks
Safety Issue:
Measure:Progression-Free Survival
Time Frame:18 months
Safety Issue:


Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Betta Pharmaceuticals Co., Ltd.

Last Updated

July 18, 2019