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An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1000394 Given Twice Daily in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies


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

Thank you

Trial Information

An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1000394 Given Twice Daily in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies


Inclusion Criteria:



- 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,
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

- At least 1 tumor lesion measurable by computer tomography (CT) scan or magnetic
resonance imaging (MRI) according to RECIST 1.1

- Adequate bone marrow, liver, and renal functions as assessed by the following
laboratory requirements to be conducted within 14 days prior to the first dose of
study drug

Exclusion Criteria:

- History of cardiac disease: congestive heart failure > NYHA Class II, unstable
angina (anginal symptoms at rest), any episodes of angina or history of myocardial
infarction, cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or
digoxin are permitted), previous venous or arterial thrombotic events, pulmonary
embolism

- Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C(3)

- History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C

- Active clinically serious infections of CTCAE > Grade 2 (CTCAE v4.02)

- Symptomatic metastatic brain or meningeal tumors unless the subject is > 3 months
from definitive therapy, has no evidence of tumor growth on an imaging study within 4
weeks prior to study entry, and is clinically stable with respect to the tumor at the
time of study entry. Subjects must not be on acute steroid therapy or taper off
steroid therapy (chronic steroid therapy is acceptable provided that the dose is
stable for 4 weeks prior to study entry and following screening CT / MRI scan).
Subjects with neurological symptoms should undergo a CT / MRI scan of the brain to
exclude new or progressive brain metastases. Spinal cord metastasis is acceptable

- Seizure disorder requiring therapy (such as steroids or anti-epileptics)

- History of organ allograft

- Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of
CTCAE > Grade 2 within 4 weeks prior to prior to the first dose of study drug

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety: Frequency of adverse events

Outcome Time Frame:

Up to 3 years or longer if indicated

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

14484

NCT ID:

NCT01188252

Start Date:

August 2010

Completion Date:

September 2014

Related Keywords:

  • Neoplasms
  • Phase I
  • Dose escalation
  • Kinase inhibitor
  • Cyclin-dependent kinases
  • Neoplasms

Name

Location

Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195