Trial Condition(s):
Tumors
Phase I study to investigate pharmacokinetics and safety of BAY73-4506 in Asian (Japanese) patients with solid tumors.
Bayer Identifier:
13172
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Mitaka, Japan, 181-8611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuo-ku, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kashiwa-shi, Japan, 277-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hidaka, Japan, 350-1298 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- 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 pharmacokineticsTimeframe: After 5 weeks (after Cycle 1).
Secondary Outcome
- BiomarkerTimeframe: At screening
- Response rateTimeframe: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks
Additional Information
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