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Copanlisib Chinese PK Study

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ClinicalTrials.gov Identifier: NCT03498430
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

This study will be conducted primarily to determine the pharmacokinetics of copanlisib in Chinese patients with relapsed iNHL.

The primary objective of the study is to determine the pharmacokinetics of copanlisib administered on Day1, 8, and 15 of a 28-days cycle (3 weeks-on/1 week off dosing regimen) as a 1 hour intravenous infusion to Chinese patients with relapsed iNHL.

The secondary objectives include the evaluation of safety, tolerability, and tumor response of Chinese patients treated with Copanlisib.

Determine the pharmacokinetics of M-1 metabolite.


Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Copanlisib (Aliqopa, BAY80-6946) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Phase I Study of Copanlisib to Evaluate the Pharmacokinetics, Safety and Tolerability in Chinese Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : June 11, 2019
Estimated Study Completion Date : September 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Copanlisib

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Cmax (Cycle 1 Day 1) of Copanlisib [ Time Frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion ]
    Cmax: maximum observed drug concentration in measured matrix after single dose administration

  2. AUC(0-24) (Cycle 1 Day 1) of Copanlisib [ Time Frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start of infusion ]
    AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose

  3. AUC(0-tlast) (Cycle 1 Day 1) of Copanlisib [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion ]

Secondary Outcome Measures :
  1. Overall response rate: proportion of patients with confirmed complete response (CR) and partial response (PR) [ Time Frame: 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) [ Time Frame: Up to about 6 months ]
  3. The number of serious drug-related TEAEs (treatment-emergent adverse events) [ Time Frame: Up to about 7 months ]
  4. The number of non-serious drug-related TEAEs [ Time Frame: Up to about 7 months ]
  5. Cmax (Cycle 1 Day 1) of M-1 metabolite [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498430


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03498430     History of Changes
Other Study ID Numbers: 16866
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Indolent Non-Hodgkin's Lymphoma (iNHL) (excluding CLL)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases