To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors

Bayer

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: BAY79-4620

Study type

Interventional

Funder types

Industry

Identifiers

NCT01028755

12671

Details and patient eligibility

About

This is the first time this drug will be tested in humans in order to determine the safety of the drug, the ability to tolerate the drug, to measure how the drug is used in the body and as a result of these tests to determine a maximum dose to be given. Specifically, the following aspects will be investigated:

side effects of BAY79-4620 given as infusion every three weeks
evaluation of highest and safest dose of BAY79-4620
distribution and concentration of BAY79-4620 in the blood at specific times after administration
effect of BAY79-4620 on tumor growth
assessment of "biomarkers" (eg, analysis of specific proteins in blood samples, or analysis of tumor tissue sampled at the time of cancer diagnosis) for changes during the treatment or prediction of safety or benefits of the treatment with BAY79-4620.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 laboratory
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 trial
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