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

This study has been terminated.
(The study was terminated due to safety reasons)
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01065623
First received: February 8, 2010
Last updated: September 3, 2013
Last verified: September 2013

February 8, 2010
September 3, 2013
April 2010
August 2010   (final data collection date for primary outcome measure)
  • Adverse Event reporting [ Time Frame: Approximately 3 years after initiation of the trial ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics profile of BAY79-4620 [ Time Frame: End of cycle 2 (14 days per cycle) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01065623 on ClinicalTrials.gov Archive Site
  • Biomarkers evaluation [ Time Frame: Approximately 3 years after initiation of the trial ] [ Designated as safety issue: Yes ]
  • Tumor response evaluation [ Time Frame: Approximately 3 years after initiation of the trial ] [ Designated as safety issue: Yes ]
  • Immunogenicity evaluation [ Time Frame: Approximately 3 years after initiation of the trial ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Study to Evaluate the Maximum Tolerated Dose of BAY79-4620 Given Every 2 Weeks to Patients With Advanced Solid Tumors
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

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

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
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
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.
 
Terminated
2
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01065623
12672, 2009-015085-58
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2013

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