Copanlisib Chinese PK Study
关键词
抽象
日期
最后验证: | 06/30/2020 |
首次提交: | 04/07/2018 |
提交的预估入学人数: | 04/07/2018 |
首次发布: | 04/12/2018 |
上次提交的更新: | 07/21/2020 |
最近更新发布: | 07/22/2020 |
实际学习开始日期: | 04/26/2018 |
预计主要完成日期: | 08/05/2019 |
预计完成日期: | 11/29/2020 |
状况或疾病
干预/治疗
Drug: Copanlisib (Aliqopa, BAY80-6946)
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Copanlisib (Aliqopa, BAY80-6946) Planned at least 12 patients who meet the entry criteria will receive 60 mg copanlisib as single agent, with dosing on Days 1, 8 and 15 of each 28-day treatment cycle | Drug: Copanlisib (Aliqopa, BAY80-6946) Copanlisib will be administered intravenously on 60mg once in a 3 weeks-on/1 week-off dose regimen (on Days 1, 8 and 15) |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Ability to understand and to sign an informed consent form. The informed consent must be signed before any study specific tests or procedures are done - Chinese, age ≥ 18 years - Patients with histologically confirmed indolent NHL (excluding chronic lymphocytic leukemia) that have relapsed and who are without past or current central nervous system involvement. - Patients must have at least 1 measurable lesion according to the Lugano Classification. - Patients affected by LPL/WM must have also measurable disease, defined as presence of IgM paraprotein with a minimum IgM level of equal to or greater than 2 times the upper limit of normal (ULN) OR over 10% of lymphoplasmacytic cells in bone marrow. - Patients with splenic MZL with splenomegaly but no measurable lesion will be considered eligible. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Life expectancy of at least 12 weeks - Left ventricular ejection fraction (LVEF) ≥ 50% - Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 x the upper limit of normal (ULN) - Adequate bone marrow, liver and renal function - Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment - Women of childbearing potential and men must agree to use highly effective contraception from signing of the informed consent form until at least 1 month after the last study drug administration. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control (failure rate of less than 1% per year), e.g. hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence Exclusion Criteria: Medical and surgical history: - Uncontrolled hypertension (Blood pressure ≥ 150/90 mmHg despite optimal medical management) - Proteinuria of CTCAE grade 3 or higher (> 3.5 g/24 h, measured by urine protein: creatinine ratio on a random urine sample) - Known bleeding diathesis. Any hemorrhage or bleeding event ≥ Grade 3 within 28 days of start of study medication. (NCI-CTCAE Version 4.03) - Uncontrolled diabetes with HbA1c ≥ 8.5% - Ongoing cytomegalovirus (CMV) infection as confirmed by positive polymerase chain reaction (PCR) for CMV Excluded previous therapies and medications: - Prior treatment with PI3K inhibitors - Anticancer chemotherapy or immunotherapy during the study or within 28 days of first study treatment. - Patients must have recovered from the toxic effects (Grade <2) of the previous anti-cancer chemotherapy or immunotherapy (with the exception of alopecia) - Biological response modifiers, such as Granulocyte colony stimulating factor (GCSF) within 14 days of first study treatment. G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the principal investigator; however they may not be substituted for a required dose reduction - Use of strong inhibitors of CYP3A4 is prohibited from Day -14 and for the duration of the study - Use of St John's Wort or strong inducers of CYP3A4 is prohibited from Day -14 and for the duration of the study |
结果
主要结果指标
1. Cmax (Cycle 1 Day 1) of Copanlisib [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion]
2. AUC(0-24) (Cycle 1 Day 1) of Copanlisib [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion]
3. AUC(0-tlast) (Cycle 1 Day 1) of Copanlisib [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion]
4. Cmax (Cycle 1 Day 15) of Copanlisib [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion]
5. AUC(0-24) (Cycle 1 Day 15) of Copanlisib [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion]
次要成果指标
1. Overall response rate: proportion of patients with confirmed complete response (CR) and partial response (PR) [Up to about 6 months]
2. Overall disease control rate: proportion of patients who have a best response rating of CR, PR or stable disease (SD) [Up to about 6 months]
3. The number of serious drug-related TEAEs (treatment-emergent adverse events) [Up to about 7 months]
4. The number of non-serious drug-related TEAEs [Up to about 7 months]
5. Cmax (Cycle 1 Day 1) of M-1 metabolite [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion]
6. AUC(0-24) (Cycle 1 Day 1) of M-1 metabolite [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion]
7. AUC(0-tlast) (Cycle 1 Day 1) of M-1 metabolite [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion]
8. Cmax (Cycle 1 Day 15) of M-1 metabolite [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion]
9. AUC(0-24) (Cycle 1 Day 15) of M-1 metabolite [Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion]