Study Completed

Lymphoma Non-Hodgkin

Bayer Identifier:

17792

ClinicalTrials.gov Identifier:

NCT02342665

EudraCT Number:

Not Available

EU CT Number:

Not Available

Japanese Phase Ib/II copanlisib in relapsed, indolent B-cell NHL

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A

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

Trial summary

Enrollment Goal

Trial Dates

April 2015 - February 2022

Phase

Phase 1/Phase 2

Could I Receive a placebo

Products

Aliqopa (Copanlisib, BAY80-6946)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Chuo-ku, 104-0045, Japan
Completed		Koto-ku, 135-8550, Japan
Completed		Sendai, 980-8574, Japan
Completed		Fukuoka, 812-8582, Japan
Completed		Nagoya, 460-0001, Japan
Completed		Nagoya, 466-8560, Japan
Completed		Nagoya, 467-8602, Japan
Completed		Kyoto, 602-8566, Japan
Completed		Kobe, 650-0017, Japan
Completed		Nagoya, 466-8650, Japan
Completed		Fukuoka, 811-1395, Japan
Completed		Nagoya, 464-8681, Japan
Completed		Maebashi, 371-8511, Japan
Withdrawn		Niigata, 951-8566, Japan
Withdrawn		Minato-ku, 105-8470, Japan

Primary Outcome

Number of participants with Adverse Events
Time Frame:
Up to 18 months
Safety Issue:
Yes
Intensity of AE
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
Safety Issue:
Yes
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)
Time Frame:
Up to 18 Years
Safety Issue:
No
Recommended dose determined in the dose escalation/safety evaluation
Time Frame:
Up to 18 months
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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