Clinical trial · Interventional
Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors
Uncontrolled, Open-label, Non-randomized, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors
- 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 will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Regorafenib
- interventionNames
- Drug: Regorafenib (Stivarga, BAY73-4506)
Primary outcomes (2)
- measure
- Pharmacokinetics as measured by cmax and AUC
- timeFrame
- Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21
- measure
- Adverse Event collection
- timeFrame
- every 1-2 weeks
Secondary outcomes (1)
- measure
- Objective tumor response rate
- timeFrame
- Every 8 weeks for the first 6 cycles, afterwards every 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female Chinese subjects \>/- 18 years * Advanced, histologically or cytologically confirmed solid tumors * Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable. * Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1; * Adequate bone marrow, liver and renal function * Life expectancy of at least 3 months Exclusion Criteria: * Unstable/uncontrolled cardiac disease * History of arterial or venous thrombotic or embolic events * Malabsorption condition * Severe renal impairment; persistent proteinuria \>/= Grade 3 * Symptomatic metastatic brain or meningeal tumors * Clinically significant bleeding \>/=Grade 3 within 30 days before start of study medication.
References
Publications (0)
Data not yet available