stop_circleTerminated/Withdrawn

Neoplasms

Bayer Identifier:

12672

ClinicalTrials.gov Identifier:

NCT01065623

EudraCT Number:

2009-015085-58

EU CT Number:

Not Available
Clinical study to evaluate the maximum tolerated dose of BAY79-4620 given every 2 weeks to patients with advanced solid tumors

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
2
Trial Dates
April 2010 - August 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY79-4620
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
University Medical Center UtrechtUTRECHT, 3584 CX, Netherlands
Terminated
Erasmus Medisch CentrumROTTERDAM, 3075 EA, Netherlands

Primary Outcome

  • Adverse Event reporting
    date_rangeTime Frame:
    Approximately 3 years after initiation of the trial
    enhanced_encryption
    Safety Issue:
    yes
  • Pharmacokinetics profile of BAY79-4620
    date_rangeTime Frame:
    End of cycle 2 (14 days per cycle)
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Biomarkers evaluation
    date_rangeTime Frame:
    Approximately 3 years after initiation of the trial
    enhanced_encryption
    Safety Issue:
    yes
  • Tumor response evaluation
    date_rangeTime Frame:
    Approximately 3 years after initiation of the trial
    enhanced_encryption
    Safety Issue:
    yes
  • Immunogenicity evaluation
    date_rangeTime Frame:
    Approximately 3 years after initiation of the trial
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.