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An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY87-2243 Given Once Daily in Subjects With Advanced Malignancies


Phase 1
18 Years
N/A
Not 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 BAY87-2243 Given Once Daily in Subjects With Advanced Malignancies


Inclusion Criteria:



- Male or female subjects aged >/= 18 years

- 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 judgement of the investigator, experimental treatment is clinically and
ethically acceptable

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2

- Life expectancy of at least 3 month

- Adequate bone marrow, liver, and renal functions

Exclusion Criteria:

- History of cardiac disease including congestive heart failure > NYHA (New York Heart
Association) II, unstable angina (anginal symptoms at rest), or new-onset angina
(within the past 3 months) or myocardial infarction within the past 6 months and
cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and
digoxin

- History of ischemic cardiovascular disease

- Family history of long QT syndrome

- Persistent hypokalemia < 3.5 mmol/L

- History of cerebral ischemia including transient ischemic attack (TIA), prolonged
reversible ischemic neurologic deficit (PRIND), and ischemic stroke within the past 6
months

- Known alcohol abuse

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

- Diabetes mellitus treated with oral antidiabetics or insulin

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

- Active clinically serious infections of CTCAE > Grade 2 (Common Terminology Criteria
for Adverse Events v4.02)

- Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 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.

- Unresolved specific chronic toxicity CTCAE > Grade 2

- Subjects may not receive potent inducers of CYP3A4, such as phenytoin, carbamazepine,
and rifampicin, as the oral clearance of ondansetron may increase and ondansetron
plasma concentrations may decrease due to antiemetic regimen

- Concomitant medication with metformin

- Concomitant medication with drugs known to prolong the QT interval

- Relevant pathological changes in the ECG such as a second or third-degree AV block,
prolongation of the QRS complex over 120 ms or of the QT / QTc-interval over 450 ms
in men and women

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:

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:

15044

NCT ID:

NCT01297530

Start Date:

April 2011

Completion Date:

July 2012

Related Keywords:

  • Neoplasms
  • Phase I
  • Dose Escalation
  • Hypoxia inducible factor 1 alpha
  • Neoplasms
  • Neoplasms

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