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An Open Label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY 1082439 Given Once Daily in Subjects With Advanced Malignancies


Phase 1
21 Years
N/A
Open (Enrolling)
Both
Neoplasms

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Trial Information

An Open Label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY 1082439 Given Once Daily in Subjects With Advanced Malignancies


Inclusion Criteria:



- 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

- 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

Exclusion Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 2 years

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Singapore: Health Sciences Authority

Study ID:

15734

NCT ID:

NCT01728311

Start Date:

November 2012

Completion Date:

September 2015

Related Keywords:

  • Neoplasms
  • Neoplasms

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