check_circleStudy Completed

Neoplasms

Bayer Identifier:

15734

ClinicalTrials.gov Identifier:

NCT01728311

EudraCT Number:

Not Available

EU CT Number:

Not Available
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
  • - Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
     -- Expansion phase only: Subjects with histologically or cytologically confirmed, locally advanced or metastatic endometrial cancer or breast cancer or iNHL, who are refractory to or have exhausted all available therapies
    - International normalized ratio (INR) and partial thromboplastin time (PTT) <1.5 x ULN [Subjects on anticoagulation with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care
    - Measurable or evaluable disease
    - Life expectancy of at least 12 weeks
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    - Adequate bone marrow, liver and renal function
  • - History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months prior to the first dose of study drug), myocardial infarction within the past 6 months prior to the first dose of study drug, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
    - Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
    - History of diabetes mellitus or gestational diabetes mellitus
    - Fasting blood glucose level >125 mg/dL or HbA1c 7% at screening
    - Active clinically serious infections > Grade 2
    - History of organ allograft
    - Seizure disorder requiring therapy (such as steroids or anti-epileptics)

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
    enhanced_encryption
    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
    enhanced_encryption
    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
    enhanced_encryption
    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
    enhanced_encryption
    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

Additional Information

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