Status:
COMPLETED
BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer
Lead Sponsor:
Bayer
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
Eligibility Criteria
Inclusion
- 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 (\</= 100 mg daily).
- 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
- 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
Key Trial Info
Start Date :
November 19 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2016
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00962611
Start Date
November 19 2009
End Date
February 23 2016
Last Update
October 6 2017
Active Locations (3)
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1
Scottsdale, Arizona, United States, 85258
2
Pittsburgh, Pennsylvania, United States, 15213
3
San Antonio, Texas, United States, 78229-3307