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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01028755
First received: November 4, 2009
Last updated: May 27, 2013
Last verified: May 2013

November 4, 2009
May 27, 2013
November 2009
April 2013   (final data collection date for primary outcome measure)
  • Safety, tolerability, maximum tolerated dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics profile of BAY79-4620 and its key metabolites [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028755 on ClinicalTrials.gov Archive Site
  • Biomarker evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors
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

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: BAY79-4620
BAY79-4620 will be administered as 1 hour IV infusion. Dose escalation will be dependent on any dose limiting toxicities
Experimental: Arm 1
Intervention: Drug: BAY79-4620
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01028755
12671
No
Head of Clinical Sciences, Bayer Healthcare Pharmaceuticals Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP