Clinical Study to Evaluate the Maximum Tolerated Dose of BAY79-4620 Given Every 2 Weeks to Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065623
Recruitment Status : Terminated (The study was terminated due to safety reasons)
First Posted : February 9, 2010
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):

Brief Summary:
Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY79-4620 given every 2 weeks to patients with advanced solid tumors

Condition or disease Intervention/treatment Phase
Neoplasms Drug: BAY79-4620 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase I Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY79-4620 Administered as an Intravenous Infusion Once Every 2 Weeks in Patients With Advanced Solid Tumors
Study Start Date : April 2010
Primary Completion Date : August 2010
Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Arm 1 Drug: BAY79-4620
1-hour infusion every 14 days. Starting dose will be 0.15 mg/ kg and dose will be escalated dependent on any dose limiting toxicities

Primary Outcome Measures :
  1. Adverse Event reporting [ Time Frame: Approximately 3 years after initiation of the trial ]
  2. Pharmacokinetics profile of BAY79-4620 [ Time Frame: End of cycle 2 (14 days per cycle) ]

Secondary Outcome Measures :
  1. Biomarkers evaluation [ Time Frame: Approximately 3 years after initiation of the trial ]
  2. Tumor response evaluation [ Time Frame: Approximately 3 years after initiation of the trial ]
  3. Immunogenicity evaluation [ Time Frame: Approximately 3 years after initiation of the trial ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The informed consent must be signed before any study specific tests or procedures are done
  • Male or female patients aged >18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Life expectancy of at least 12 weeks
  • Patients with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or patients must have actively refused any treatment which would be regarded standard, and/or if in the judgment of the investigator or his designated associate(s), experimental treatment is clinically and ethically acceptable
  • Radiographically or clinically evaluable tumor
  • Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to start of first dose

Exclusion Criteria:

  • History of cardiac disease: congestive heart failure (CHF) > NYHA Class II; myocardial infarction within 3 months prior to study entry; new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
  • Uncontrolled hypertension defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 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 of Common Terminology Criteria for Adverse Events Version 3 (CTCAE v3.0) > Grade 2
  • Serious, non-healing wound, ulcer, or bone fracture
  • Major surgery, open biopsy, or significant trauma within 4 weeks prior to the first dose of study drug
  • Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks of start of first dose
  • Radiotherapy to the target lesions within 3 weeks prior to Cycle 1 Day 1 (first dose of study drug). Palliative radiotherapy will be allowed as described in the study protocol. Radiotherapy to the target lesions during study will be regarded as progressive disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065623

Rotterdam, Netherlands, 3075 EA
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01065623     History of Changes
Other Study ID Numbers: 12672
2009-015085-58 ( EudraCT Number )
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Keywords provided by Bayer:
Phase I
Dose escalation

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs