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Lymphoma, Non-HodgkinPhase 1NCT03498430

Copanlisib Chinese PK Study

A Phase 1 study testing Copanlisib (Aliqopa, BAY80-6946) in people with Lymphoma, Non-Hodgkin, run by Bayer at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
Copanlisib (Aliqopa, BAY80-6946)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteChina
Study dates
27 Apr 2018to 2 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, 100142

Other trials in China

About this study

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)

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.

Being tested
Copanlisib (Aliqopa, BAY80-6946)
Keywords
Indolent Non-Hodgkin's Lymphoma (iNHL) (excluding CLL)
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Copanlisib (Aliqopa, BAY80-6946)Drug

    Copanlisib will be administered intravenously on 60mg once in a 3 weeks-on/1 week-off dose regimen (on Days 1, 8 and 15)

Study groups in NCT03498430
Study groupRoleWhat they receive
Copanlisib (Aliqopa, BAY80-6946)ExperimentalPlanned 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
Receives: Drug: Copanlisib (Aliqopa, BAY80-6946)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax (Cycle 1 Day 1) of Copanlisib

    Cmax: maximum observed drug concentration in measured matrix after single dose administration

    Measured: 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

    AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion

Secondary outcomes (9)

  1. Overall response rate: proportion of patients with confirmed complete response (CR) and partial response (PR)

    Measured: 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)

    Measured: Up to about 6 months

  3. The number of serious drug-related TEAEs (treatment-emergent adverse events)

    Measured: Up to about 7 months

  4. The number of non-serious drug-related TEAEs

    Measured: Up to about 7 months

  5. Cmax (Cycle 1 Day 1) of M-1 metabolite

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11 and 24 hours after start of infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2018
  2. Study start27 Apr 2018
  3. Primary completion6 Aug 2019
  4. Study completion2 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03498430
Sponsor's protocol ID
16866
Status last verified
May 2021
First submitted
8 Apr 2018
Last updated
19 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu W, Ping L, Xie Y, Sun Y, Du T, Niu Y, Cisternas G, Huang F, Garcia-Vargas J, Childs BH, Mehra A, Reschke S, Wang X, Song Y, Zhu J. A phase I pharmacokinetic study of copanlisib in Chinese patients with relapsed indolent non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2022 Jun;89(6):825-831. doi: 10.1007/s00280-022-04417-3. Epub 2022 Mar 23.

    PubMed 35322287

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Copanlisib (Aliqopa, BAY80-6946) in people with Lymphoma, Non-Hodgkin, run by Bayer at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03498430, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.

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