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Copanlisib Chinese PK Study

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ClinicalTrials.gov Identifier: NCT03498430
Recruitment Status : Not yet recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 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 advanced cancer.

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 advanced cancer.

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


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase I Study of Copanlisib to Evaluate the Pharmacokinetics, Safety and Tolerability in Chinese Patients With Advanced Cancer
Estimated Study Start Date : April 30, 2018
Estimated Primary Completion Date : June 11, 2019
Estimated Study Completion Date : September 3, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Copanlisib (BAY80-6946)
Planned 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 (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. Time to progression (TTP) [ Time Frame: Up to about 6 months ]
  4. Progression-free survival (PFS) [ Time Frame: Up to about 6 months ]
  5. The number of serious drug-related TEAEs (treatment-emergent adverse events) [ Time Frame: Up to about 7 months ]
  6. The number of non-serious drug-related TEAEs [ Time Frame: Up to about 7 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  • Subjects with histologically or cytologically confirmed malignant solid tumor or NHL (excluding chronic lymphocytic leukemia) that are advanced and refractory to any standard therapy or have no standard therapy available and who are without past or current central nervous system involvement
  • NHL patients must have at least 1 measurable lesion according to the Lugano criteria.

Patients with solid tumors must have at least 1 measurable or non-measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to the RECIST 1.1 criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) for the institution
  • 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 adequate contraception from signing of the informed consent form until at least 3 months after the last study drug administration. The investigator or a designated associate is requested to advise the patient how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods)

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)
  • Current diagnosis of Type I or II diabetes mellitus or fasting plasma glucose level >125mg/dL at screening, and/or HbA1c ≥6. 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 28 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@bayerhealthcare.com

Locations
China
Beijing Cancer Hospital Not yet 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: April 13, 2018
Last Verified: April 2018

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

Keywords provided by Bayer:
Advanced malignant solid tumor
Refractory malignant solid tumor
Non-Hodgkin´s lymphoma (NHL) (excluding CLL)

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