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

Primary Purpose

Lymphoma Non-Hodgkin

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Copanlisib (BAY80-6946)

About this trial

This is an interventional treatment trial for Lymphoma Non-Hodgkin focused on measuring Non Hodgkin's Lymphomas

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Copanlisib (BAY80-6946)

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with Adverse Events

Intensity of AE

The NCI Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) will be used to assess the intensity of AE

Objective Tumor Response (OR)

OR: Best response rating of complete response or partial response according to the criteria defined in the Revised Response Criteria for Malignant Lymphoma(JClin Oncol.2007 Feb)

Recommended dose determined in the dose escalation/safety evaluation

Secondary Outcome Measures

Full Information

NCT ID

NCT02342665

First Posted

January 15, 2015

Last Updated

January 19, 2023

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02342665

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

April 21, 2015 (Actual)

Primary Completion Date

September 14, 2018 (Actual)

Study Completion Date

February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma Non-Hodgkin

Keywords

Non Hodgkin's Lymphomas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Copanlisib (BAY80-6946)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Copanlisib (BAY80-6946)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Number of participants with Adverse Events

Time Frame

Up to 18 months

Title

Intensity of AE

Description

The NCI Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) will be used to assess the intensity of AE

Time Frame

Up to 18 months

Title

Objective Tumor Response (OR)

Description

OR: Best response rating of complete response or partial response according to the criteria defined in the Revised Response Criteria for Malignant Lymphoma(JClin Oncol.2007 Feb)

Time Frame

Up to 18 Years

Title

Recommended dose determined in the dose escalation/safety evaluation

Time Frame

Up to 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0001

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-8560

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-8650

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

467-8602

Country

Japan

City

Maebashi

State/Province

Gunma

ZIP/Postal Code

371-8511

Country

Japan

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

City

Koto-ku

State/Province

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

City

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://clinicaltrials.bayer.com/

Description

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

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

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