check_circleStudy Completed

Lymphoma, Non-Hodgkin

Copanlisib Chinese PK study

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
13
Trial Dates
April 2018 - June 2020
Phase
Phase 1
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Beijing Cancer HospitalBeijing, 100142, China

Primary Outcome

  • Cmax (Cycle 1 Day 1) of Copanlisib
    Cmax: maximum observed drug concentration in measured matrix after single dose administration
    date_rangeTime 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(0-24) (Cycle 1 Day 1) of Copanlisib
    AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose
    date_rangeTime 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(0-tlast) (Cycle 1 Day 1) of Copanlisib
    date_rangeTime 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 (Cycle 1 Day 15) of Copanlisib
    date_rangeTime Frame:
    Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion
  • AUC(0-24) (Cycle 1 Day 15) of Copanlisib
    date_rangeTime Frame:
    Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion

Secondary Outcome

  • Overall response rate: proportion of patients with confirmed complete response (CR) and partial response (PR)
    date_rangeTime Frame:
    Up to about 6 months
  • Overall disease control rate: proportion of patients who have a best response rating of CR, PR or stable disease (SD)
    date_rangeTime Frame:
    Up to about 6 months
  • The number of serious drug-related TEAEs (treatment-emergent adverse events)
    date_rangeTime Frame:
    Up to about 7 months
  • The number of non-serious drug-related TEAEs
    date_rangeTime Frame:
    Up to about 7 months
  • Cmax (Cycle 1 Day 1) of M-1 metabolite
    date_rangeTime 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(0-24) (Cycle 1 Day 1) of M-1 metabolite
    date_rangeTime 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(0-tlast) (Cycle 1 Day 1) of M-1 metabolite
    date_rangeTime 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 (Cycle 1 Day 15) of M-1 metabolite
    date_rangeTime Frame:
    Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion
  • AUC(0-24) (Cycle 1 Day 15) of M-1 metabolite
    date_rangeTime Frame:
    Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1