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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


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

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Characterize safety, tolerability + pharmacokinetics, to determine the maximum tolerated dose of BAY80-6946 administered 1x weekly for 3 weeks, every 4weeks, as a 1h-intravenous infusion. Evaluate biomarkers that may be predictive of tumor response.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

12871

NCT ID:

NCT00962611

Start Date:

November 2009

Completion Date:

January 2015

Related Keywords:

  • Neoplasms
  • Solid tumors
  • Advanced cancer
  • Neoplasms

Name

Location

Phoenix, Arizona  85012
Philadelphia, Pennsylvania  19104
Austin, Texas  78705