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NeoplasmsPhase 1NCT02047890

Japanese BAY1000394 Monotherapy Phase I Study

A Phase 1 study testing BAY1000394 (2.5mg) and BAY1000394 (5mg) in people with Neoplasms, run by Bayer at 2 sites in Japan.

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 is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety, tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in Japanese subjects with advanced malignancies. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Neoplasms
What is being tested?
BAY1000394 (2.5mg) and BAY1000394 (5mg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesJapan
Study dates
19 May 2014to 19 Jul 2018
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Japanese male or female subjects aged ≥20 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  • Life expectancy of at least 12 weeks
  • Subjects with advanced, histologically or cytologically confirmed solid tumors, not amenable to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
  • At least 1 tumor lesion evaluable by computer tomography (CT) or scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Adequate bone marrow, liver, and renal functions

Who cannot join

  • Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry.
  • Radiotherapy to target lesions within 3 weeks prior to the first dose of study drug.
  • Use of biological response modifiers, such as granulocyte colony-stimulating factor (G-CSF), within 3 weeks prior to the first dose of study drug.
  • Symptomatic metastatic brain or meningeal tumors.
  • Investigational drug treatment outside of this study during or within 4 weeks prior to study entry.
  • Blood pressure <100/60 mmHg or pulse >100 BPM

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Study site

    Fukuoka, 811-1395

  • Study site

    Kashiwa, Chiba, 277-8577

Other trials in Japan

About this study

Official title: An Open-label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics of BAY1000394 Given in a 3 Days on / 4 Days Off Schedule in Japanese Subjects With Advanced Malignancies

This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety, tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in Japanese subjects with advanced malignancies.

Conditions
Neoplasms
Being tested
BAY1000394 (2.5mg), BAY1000394 (5mg)
Keywords
CDK inhibitor, BAY1000394, Advanced malignancies, Japanese
Medical subject headings
Neoplasms

What participants receive

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

  • BAY1000394 (2.5mg)Drug

    BAY1000934 2.5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 1)

  • BAY1000394 (5mg)Drug

    BAY1000934 5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 2)

Study groups in NCT02047890
Study groupRoleWhat they receive
BAY1000394ExperimentalApproximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).
Receives: Drug: BAY1000394 (2.5mg); Drug: BAY1000394 (5mg)

What is being measured

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

  1. Number of participants with adverse events as a measure of safety and tolerability

    Measured: 6 months

  2. Number of participants with abnormal lab parameters based on descriptive statistics

    Measured: 6 months

  3. Maximum observed drug concentration (Cmax) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  4. Cmax divided by dose per body weight (Cmax,norm) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  5. Cmax divided by dose (Cmax/D) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  6. Area under the concentration versus time curve from zero to infinity after single dose (AUC) for BAY1000394 and its metabolite M-1

    Measured: = Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose)

  7. AUC from time 0 to 12 hours after single dose (AUC(0-12) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8 and 12 hours

  8. AUC divided by dose per body weight (AUCnorm) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose)

  9. AUCnorm from time 0 to 12 hours after single dose (AUC(0-12),norm) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8 and 12 hours

  10. AUC divided by dose (AUC/D) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose)

  11. Time to reach Cmax (tmax) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  12. Terminal half-life (t½) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  13. Maximum observed drug concentration after multiple dosing (Cmax,md) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  14. Cmax divided by dose per body weight after multiple dosing (Cmax,norm,md) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  15. Cmax divided by dose (Cmax,md/D) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  16. AUC from time 0 to 12 hours after multiple dosing (AUC(0-12),md) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  17. AUCnorm from time 0 to 12 hours after multiple dosing (AUC(0-12),norm,md) for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

  18. AUC from time 0 to 12 hours divided by dose after multiple dosing for BAY1000394 and its metabolite M-1

    Measured: Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

Secondary outcomes (1)

  1. Tumor response

    Measured: Screening and on Day 21 of even numbered cycle

Timeline

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

  1. First posted28 Jan 2014 (estimated)
  2. Study start19 May 2014
  3. Primary completion6 Jan 2015
  4. Study completion19 Jul 2018

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02047890
Sponsor's protocol ID
15200
Status last verified
Jun 2019
First submitted
27 Jan 2014
Last updated
24 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1000394 (2.5mg) and BAY1000394 (5mg) in people with Neoplasms, run by Bayer at 2 sites in Japan.

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 6 inclusion and 6 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 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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?

Number of participants with adverse events as a measure of safety and tolerability (time frame: 6 months). The study lists 18 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 NCT02047890.

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 24 Jun 2019.

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