NCT01065623TerminatedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Bayer
- Enrollment
- 2
- Primary Endpoint
- Adverse Event reporting
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Arm 1
Experimental
Intervention: BAY79-4620 (Drug)
Outcomes
Primary Outcomes
Adverse Event reporting
Time Frame: Approximately 3 years after initiation of the trial
Pharmacokinetics profile of BAY79-4620
Time Frame: End of cycle 2 (14 days per cycle)
Secondary Outcomes
- Tumor response evaluation(Approximately 3 years after initiation of the trial)
- Biomarkers evaluation(Approximately 3 years after initiation of the trial)
- Immunogenicity evaluation(Approximately 3 years after initiation of the trial)
Investigators
Similar Trials
Completed
Phase 1
Clinical Study to Evaluate the Maximum Tolerated Dose of BAY1000394 Given in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced MalignanciesNeoplasmsNCT01188252Bayer112
Not yet recruiting
Phase 1
Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy VolunteersChronic Spontaneous UrticariaNCT04404023UBP Greater China (Shanghai) Co., Ltd15
Completed
Phase 1
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU PatientsUrticaria ChronicNCT03632291United BioPharma15
Completed
Phase 1
Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular CarcinomaCarcinoma, HepatocellularNCT01594125Boehringer Ingelheim30
Completed
Phase 1
Study of ALXN1850 in Participants With Hypophosphatasia (HPP)HypophosphatasiaNCT04980248Alexion Pharmaceuticals, Inc.15