check_circleStudy Completed

Neoplasms

Open label study of BAY1082439 in patients with advanced cancer

Trial purpose

The purpose of this study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439

Key Participants Requirements

Sex

Both

Age

21 - N/A

Trial summary

Enrollment Goal
60
Trial Dates
November 2012 - February 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1082439
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Singapore, 119228, Singapore
Completed
Singapore, 169610, Singapore
Completed
Seoul, 120-752, Korea, Republic Of
Completed
Taipei, 10002, Taiwan
Completed
Seoul, 03080, Korea, Republic Of
Withdrawn
Houston, 77030, United States
Withdrawn
St. Louis, 63110, United States
Withdrawn
Ann Arbor, 48109, United States
Withdrawn
Dallas, 75201, United States
Withdrawn
Tainan, 70428, Taiwan

Primary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 2 years
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    Safety Issue:
    Yes
  • Maximum tolerated dose of BAY1082439
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum observed plasma concentration (Cmax) of BAY1082439 after a single dose
    date_rangeTime Frame:
    Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
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    Safety Issue:
    No
  • Time to Cmax (tmax) of BAY1082439 after a single dose
    date_rangeTime Frame:
    Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
    enhanced_encryption
    Safety Issue:
    No
  • Area under the plasma concentration-time curve (AUC[0-t]) of BAY1082439 after a single dose
    date_rangeTime Frame:
    Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
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    Safety Issue:
    No

Secondary Outcome

  • Area under the concentration-time curve over the dosing interval (AUC[0-tau])
    date_rangeTime Frame:
    PK parameters following single and repeat-dose administration in cycle 1
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    Safety Issue:
    No
  • Maximum observed concentration (Cmax)
    date_rangeTime Frame:
    PK parameters following single and repeat-dose administration in cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • Time of occurrence of Cmax (tmax)
    date_rangeTime Frame:
    PK parameters following single and repeat-dose administration in cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • Terminal phase half-life (t1/2)
    date_rangeTime Frame:
    PK parameters following single and repeat-dose administration in cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • Tumor response based on Response Evaluation Criteria in Solid Tumors, Version 1.1
    date_rangeTime Frame:
    Up to 2 years

Trial design

An open-label Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY 1082439 given once daily continuously or in an intermittent dosing schedule in subjects with advanced malignancies
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1