Lymphoma Non-Hodgkin
Conditions
Interventions
investigational material(s)
Generic name etc : BAY 80-6946
INN of investigational material : copanlisib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigati
Sponsors
Bayer Yakuhin, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following: Follicular lymphoma (FL) grade 1-2-3a Small lymphocytic lymphoma (SLL) with absolute lymphocyte count = 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have previously received rituximab and alkylating agent(s). - Japanese patients >= 20 years of age - ECOG performance status == lower limit of normal (LLN) for the Institution - Availability of fresh or archival tumor tissue
Exclusion criteria
Exclusion criteria: - Uncontrolled hypertension (blood pressure >= 150/90 mmHg, defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management) - Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >= CTCAE Grade 3 (NCI-CTC version 4.0) within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events, NCI: National Cancer Institute). - History or concurrent condition of interstitial lung disease or severely impaired pulmonary function - Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure excluding alopecia. - Prior treatment with PI3K inhibitors - Systemic corticosteroid therapy (ongoing) - Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at Screening - Known history of human immunodeficiency virus (HIV) infection. - Hepatitis B (HBV) or hepatitis C (HBC). All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA. - Known lymphomatous involvement of the central nervous system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Adverse Events, objective response - The NCI Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) will be used to assess for AE. - Objective response will be used for Revised Response Criteria for malignant Lymphoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics other | — |
Countries
Japan
Contacts
Public Contactcontact Dedicated
Bayer Yakuhin, Ltd.
Outcome results
None listed