Clinical trial · Interventional
Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.
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
NCT00960258CI-TRIAL-00029672completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib (BAY73-4506) | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Regorafenib (BAY73-4506)
Primary outcomes (1)
- 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
- timeFrame
- After 5 weeks (after Cycle 1).
Secondary outcomes (2)
- measure
- Biomarker
- timeFrame
- At screening
- measure
- Response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.