Clinical trial NCT01028755: To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Maximum Tolerated Dose
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety, tolerability, maximum tolerated dose
timeFrame: 2 years
measure: Pharmacokinetics profile of BAY79-4620 and its key metabolites
timeFrame: 2 years
Secondary outcomes:
measure: Biomarker evaluation
timeFrame: 2 years
measure: Tumor response
timeFrame: 2 years
measure: Immunogenicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Nashville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: