Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: A Study to Investigate BGB-3111 in Chinese Patients With B-cell Lymphoma

Summary: This phase I clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of BTK inhibitor BGB-3111 in Chinese patients with B-cell lymphoma, by conducting in two stages, the first stage being the safety assessment of dose, and the second stage being the dose expansion.
  Part I: Safety evaluation - according to the results of preclinical toxicological trials and the results of the phase I clinical study conducted in Australia and New Zealand, two regimens of BGB-3111 320 mg daily (160 mg BID, administered in the morning and at night, or 320 mg QD) and "3+3" design is adopted for the assessment. The recommended dose and method of administration of phase II clinical study will be determined according to the Part I results.
  Part II: Dose expansion - this stage is to further evaluate the preliminary anti-tumor effects of BGB-3111 in Chinese subjects with follicular lymphoma (FL) or marginal zone lymphoma (MZL), approximately 20 subjects with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) will be enrolled. The recommended Phase 2 dose will be used in the Part II.


Eligibility: Inclusion Criteria:
  -  Men and women with the age of 18-75 years
  -  Subjects with B-cell lymphoma (defined by WHO classification) refractory or relapsed following at least one line of therapy
  -  Judged by the investigator as requiring treatment.
  -  ECOG performance status of 0-1.
  -  Life expectancy of at least 4 months.
  -  Adequate hematological function
  -  Adequate renal function
  -  Adequate liver function
  -  Adequate Coagulation function
  -  Female subjects of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
  -  Male subjects must not donate sperm from start of study drug administration, until 90 days after discontinuation of treatment.
  Exclusion Criteria:
  -  With CNS involvement of the disease.
  -  The pathological type of the disease has Disease transformation.
  -  Has underdone allogeneic hematopoietic stem cell transplantation.
  -  Has received corticosteroid anti-neoplastic treatment within 7 days before the first dose, has received radiotherapy and chemotherapy within 4 weeks before the first dose or has received treatment with monoclonal antibody within 4 weeks before the first dose.
  -  Has received BTK inhibitor treatment prior to enrollment.
  -  Has received chemotherapy and has not yet recovered from toxicity
  -  Has received Chinese herbal medicine as anti-neoplastic therapy within 4 weeks before starting study treatment.
  -  History of other malignancies within 2 years before study
  -  With uncontrolled systemic infection.
  -  Major surgery in the past 4 weeks.
  -  With known HIV, or active hepatitis B or hepatitis C virus infection.
  -  With cardiovascular disease of New York Heart Association (NYHA) Classification ≥ 3.
  -  Significant ECG abnormalities
  -  Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participation in the study.
  -  Inability to comply with study procedures.
  -  Currently taking anticoagulant drugs.
  -  Currently taking potent CYP3A inhibitor or inducer
  -  Had stroke or cerebral hemorrhage within 6 months before enrollment.

Relevance to patient case: not relevant