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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copanlisib (BAY80-6946) | Experimental | Dose escalation/safety evaluation cohort and objective tumor response (OR) expansion cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copanlisib (BAY80-6946) | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | Up to 18 months | |
| Intensity of AE | The NCI Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) will be used to assess the intensity of AE | Up to 18 months |
| 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) | Up to 18 Years |
| Recommended dose determined in the dose escalation/safety evaluation | Up to 18 months |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 460-0001 | Japan | |||
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000589253 | copanlisib |
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| Nagoya |
| Aichi-ken |
| 464-8681 |
| Japan |
| Nagoya | Aichi-ken | 466-8560 | Japan |
| Nagoya | Aichi-ken | 466-8650 | Japan |
| Nagoya | Aichi-ken | 467-8602 | Japan |
| Maebashi | Gunma | 371-8511 | Japan |
| Kobe | Hyōgo | 650-0017 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Chuo-ku | Tokyo | 104-0045 | Japan |
| Koto-ku | Tokyo | 135-8550 | Japan |
| Fukuoka | 811-1395 | Japan |
| Fukuoka | 812-8582 | Japan |
| Kyoto | 602-8566 | Japan |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |