Phase I, Uncontrolled, Open-label, Non-randomized Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Advanced, Refractory Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Tumors
Both
Tumors
Trial Information
Phase I, Uncontrolled, Open-label, Non-randomized Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Advanced, Refractory Solid Tumors
Inclusion Criteria:
- Male or female Japanese patients >/= 18 years
- Histologically or cytologically confirmed solid tumors
- ECOG-PS 0 - 1
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Uncontrolled hypertension
- Patients with severe renal impairment or on dialysis
- Patients with seizure disorder requiring anticonvulsant medication
- Known or suspected allergy to the investigational agent.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics
Outcome Time Frame:
After 5 weeks (after Cycle 1).
Safety Issue:
Yes
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
13172
NCT ID:
NCT00960258
Start Date:
July 2009
Completion Date:
March 2014
Related Keywords:
- Tumors
- Solid Tumors
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