BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/8/2017
Start Date:November 19, 2009
End Date:February 23, 2016

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An Open Label Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Maximum Tolerated Dose and Biomarker Response After Intravenous Administration of Weekly BAY80-6946 to Patients With Advanced Cancer

The purpose of this study is to determine the tolerability, maximum tolerated dose and
pharmacokinetics of this drug.


Inclusion Criteria:

- Age >/= 18 years.

- Histological or cytological documentation of non-hematologic, malignant solid tumor,
excluding primary brain or spinal tumors, or history of central nervous system
metastases

- At least one measurable lesion or evaluable disease

- Life expectancy of at least 12 weeks

- ECOG Performance Status of 0, 1 or 2

- PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically
anticoagulated 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]. Low-dose aspirin is permitted (
- Adequate bone marrow, liver and renal function

- Ability to understand and to sign an informed consent form; a signed informed consent
must be obtained prior to any study specific procedures

Exclusion Criteria:

- History of cardiac disease congestive heart failure (CHF) > NYHA Class II; active
coronary artery disease, myocardial infarction within 6 months prior to study entry;
new onset angina within 3 months prior to study entry or unstable angina or cardiac
arrhythmias requiring anti-arrhythmic therapy (beta-blockers or Digoxin are
permitted).

- Current diagnosis of type I or II diabetes mellitus or fasting blood glucose level
>125 mg/dL at screening, or HbA1c 7%

- Active clinically serious infections > Grade 2 (NCI-CTCAE Version 3.0)

- History of having received allogeneic organ transplant

- Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic
drugs (phenytoin, carbamazepine or phenobarbital) is not allowed throughout the entire
study.

- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
pressure > 90 mmHg, despite optimal medical management
We found this trial at
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