Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL

NCT ID: NCT02342665

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-21
• Study Completion Date: 2022-02-10

Brief Summary

The primary objective of this study is to assess the safety profile of copanlisib at the recommended dose (primary endpoint). The recommended dose of copanlisib for Japanese patients will be determined in the dose escalation/safety evaluation part.

Conditions

Lymphoma Non-Hodgkin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Copanlisib (BAY80-6946)

Dose escalation/safety evaluation cohort and objective tumor response (OR) expansion cohort

Group Type: EXPERIMENTAL

Copanlisib (BAY80-6946)

Intervention Type: DRUG

Dosing is weekly for the first 3 weeks (on Days 1, 8, and 15) of a 28-day cycle, followed by a 1-week break (i.e., no infusion on Day 22).

Interventions

Copanlisib (BAY80-6946)

Dosing is weekly for the first 3 weeks (on Days 1, 8, and 15) of a 28-day cycle, followed by a 1-week break (i.e., no infusion on Day 22).

Intervention Type: DRUG

Eligibility 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 < 5 x 109/L at the time of diagnosis and at study entry Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM) Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

• Relapsed or refractory after ≥ 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 ≤ 2 (Eastern Cooperative Oncology Group:ECOG)
• Life expectancy of at least 3 months
• Adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment
• Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) for the Institution
• Availability of fresh or archival tumor tissue

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 or C requiring treatment
• Cytomegalovirus (CMV) PCR positive at baseline
• Known lymphomatous involvement of the central nervous system

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Maebashi, Gunma, Japan

Kobe, Hyōgo, Japan

Sendai, Miyagi, Japan

Chuo-ku, Tokyo, Japan

Koto-ku, Tokyo, Japan

Fukuoka, , Japan

Fukuoka, , Japan

Kyoto, , Japan

Countries

Japan

Related Links

http://clinicaltrials.bayer.com/

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Other Identifiers

17792

Identifier Type: -

Identifier Source: org_study_id