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Completed

NCT Number: NCT02047890

Japanese BAY1000394 Monotherapy Phase I Study

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.

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Key information

Conditions

Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: = 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary outcomes

  1. Tumor response

    Time frame: Screening and on Day 21 of even numbered cycle

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Jan 28, 2014
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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