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
  Purpose

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.

Condition Intervention Phase
Neoplasms
Drug: BAY79-4620
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: November 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY79-4620
BAY79-4620 will be administered as 1 hour IV infusion. Dose escalation will be dependent on any dose limiting toxicities

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028755

Locations
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
San Antonio, Texas, United States, 78229-3307
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head of Clinical Sciences, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01028755     History of Changes
Other Study ID Numbers: 12671
Study First Received: November 4, 2009
Last Updated: May 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Maximum Tolerated Dose

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014