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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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).
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Number of participants with Adverse Events
Time frame: 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
Time frame: 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)
Time frame: Up to 18 Years
Recommended dose determined in the dose escalation/safety evaluation
Time frame: Up to 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Maebashi, Gunma, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Sendai, Miyagi, Japan
Unnamed facility
Chuo-ku, Tokyo, Japan
Unnamed facility
Koto-ku, Tokyo, Japan
...and 3 more locations