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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 January 2023
• Main ID: NCT02342665
• Date of registration: 15/01/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL
• Scientific title: Open-label, Uncontrolled, Single-arm, Phase Ib/II Study of Intravenous Copanlisib in Japanese Patients With Indolent B-cell Non Hodgkin's Lymphomas Relapsed After or Refractory to Standard Therapy
• Date of first enrolment: April 21, 2015
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02342665
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Japan

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lymphoma Non-Hodgkin

Intervention(s)

Drug: Copanlisib (BAY80-6946)

Primary Outcome(s)

Intensity of AE [Time Frame: Up to 18 months]

Number of participants with Adverse Events [Time Frame: Up to 18 months]

Recommended dose determined in the dose escalation/safety evaluation [Time Frame: Up to 18 months]

Objective Tumor Response (OR) [Time Frame: Up to 18 Years]

Secondary ID(s)

17792

Source(s) of Monetary Support

Please refer to primary and secondary sponsors