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An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors

Inclusion Criteria:

- Age greater than/equal to 18 years old.

- ECOG Performance Status of 0 - 2

- Life expectancy of at least 12 weeks

- Patients with advanced, histologically or cytological confirmed solid tumors,
refractory to any standard therapy or have no standard therapy available

- Radiographically or clinically evaluable tumor

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

- Hemoglobin > 10.0 g/dL

- Absolute neutrophil count (ANC) > or = 1500/mm3

- Platelet count > or = 100,000 /mm3

- Total bilirubin < or = 1.5 times the upper limit of normal

- ALT and AST < or = 2.5 x upper limit of normal (< or = 5 x upper limit of normal for
patients with liver involvement)

- INR less than or = 1.5 and a PTT within normal limits (patients who do not undergo an
anticoagulative treatment, but have an abnormal high PTT while INR is normal,
indicating towards an artificial PTT elevation caused by heparinized, are eligible.

- Serum creatinine < 1.5 times the upper limit of normal

Exclusion Criteria:

- History of impaired cardiac function or clinically significant cardiac disease (i.e.
congestive heart failure (CHF) NYHA Class III or IV); myocardial infarction, unstable
angina or cardiac arrhythmias requiring anti-arrhythmic therapy < 6 months prior to
study entry (beta blockers or digoxin are permitted) and LVEF <40% (as measured at
screening by MUGA or echocardiogram).

- Patients with amylase or lipase greater than upper limit of normal range per local

- History of pancreatitis

- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or
diastolic blood pressure > 90 mmHg, despite optimal medical management

- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months
from definitive therapy, has no evidence of tumor growth on an imaging study within 2
weeks prior to study entry, and is clinically stable with respect to the tumor at the
time of study entry.

- Patients with severe renal impairment or on dialysis

- Known human immunodeficiency virus (HIV) infection or patients with an active
hepatitis B or C infection necessitating treatment. Patients with chronic hepatitis
B or C are eligible

- Active clinically serious infections > CTCAE Grade 2

- Serious, non-healing wound, ulcer, or bone fracture

- Known or suspected allergy or intolerance to any agent given in the course of this

- Previous cancer that is distinct in primary site or histology from actual disease
EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder
tumors [Ta and Tis] or any cancer curatively treated > 3 years prior to study entry

Type of Study:


Study Design:

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

Outcome Measure:

Safety, tolerability, maximum tolerated dose

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

April 2013

Related Keywords:

  • Neoplasms
  • Maximum Tolerated Dose
  • Neoplasms



Nashville, Tennessee  37203-1632
Austin, Texas  78705