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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02342665

Collaborator

(none)

Enrollment

Locations

Arm

81.7

Actual Duration (Months)

1.9

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Non-Hodgkin	Drug: Copanlisib (BAY80-6946)	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 21, 2015

Actual Primary Completion Date :

Sep 14, 2018

Actual Study Completion Date :

Feb 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Copanlisib (BAY80-6946) Dose escalation/safety evaluation cohort and objective tumor response (OR) expansion cohort	Drug: 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).

Arm

Intervention/Treatment

Experimental: Copanlisib (BAY80-6946)

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

Drug: 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).

Outcome Measures

Primary Outcome Measures

Number of participants with Adverse Events [Up to 18 months]
Intensity of AE [Up to 18 months]
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) [Up to 18 Years]
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 [Up to 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Nagoya	Aichi	Japan	460-0001
2	Nagoya	Aichi	Japan	464-8681
3	Nagoya	Aichi	Japan	466-8560
4	Nagoya	Aichi	Japan	466-8650
5	Nagoya	Aichi	Japan	467-8602
6	Maebashi	Gunma	Japan	371-8511
7	Kobe	Hyogo	Japan	650-0017
8	Sendai	Miyagi	Japan	980-8574
9	Chuo-ku	Tokyo	Japan	104-0045
10	Koto-ku	Tokyo	Japan	135-8550
11	Fukuoka		Japan	811-1395
12	Fukuoka		Japan	812-8582
13	Kyoto		Japan	602-8566

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT02342665

Other Study ID Numbers:

17792

First Posted:

Jan 21, 2015

Last Update Posted:

Feb 22, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bayer

Non Hodgkin's Lymphomas

Additional relevant MeSH terms:

Lymphoma

Study Results

No Results Posted as of Feb 22, 2022