check_circleStudy Completed

Neoplasms

Clinical study to evaluate safety and maximum tolerated dose of BAY1000394 given in a 4 week on / 2 week off schedule in subjects with advanced malignancies

Trial purpose

Clinical study to determine safety, tolerability, and maximum tolerated dose of BAY1000394 given in 4 week on / 2 week off schedule to patients with advanced solid tumors

Key Participants Requirements

Sex

Female

Age

18 - N/A

Trial summary

Enrollment Goal
10
Trial Dates
December 2010 - September 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Scottsdale, 85258, United States
Completed
St. Louis, 63110, United States
Completed
Chapel Hill, 27599, United States

Primary Outcome

  • Number of subjects with Adverse Events as a measure safety
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
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    Safety Issue:
    Yes
  • Maximum tolerated dose: Measured by adverse event profile
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
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    Safety Issue:
    Yes

Secondary Outcome

  • Biomarkers evaluation measured by Enzyme-linked immunosorbent assay (ELISA)
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
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    Safety Issue:
    Yes
  • Tumor Response evaluation measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
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    Safety Issue:
    Yes
  • Peak Plasma Concentration (Cmax) of BAY1000394
    date_rangeTime Frame:
    Approximately 18 months
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    Safety Issue:
    No
  • Pharmacokinetics parameters will be measured using Peak Plasma Time (tmax) of BAY1000394
    date_rangeTime Frame:
    Approximately 18 months
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    Safety Issue:
    No
  • Area under the plasma concentration versus time curve from 0 to tn (AUC(0 tn)) of BAY1000394
    date_rangeTime Frame:
    Approximately 18 months
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    Safety Issue:
    No
  • Area under the plasma concentration versus time curve (AUC) of BAY1000394
    date_rangeTime Frame:
    Approximately 18 months
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    Safety Issue:
    No
  • Half-life of BAY1000394
    date_rangeTime Frame:
    Approximately 18 months
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    Safety Issue:
    No

Trial design

An open-label, Phase I, dose-escalation study to characterize the safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY1000394 given in a 4 week on / 2 week off schedule in subjects with advanced malignancies
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1