Clinical trial · Observational
Regorafenib Post-marketing Surveillance in Japan
Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy
NCT01933958CI-TRIAL-00057483completedClinicalTrials.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)
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice
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 |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy.
- interventionNames
- Drug: Regorafenib (Stivarga, BAY73-4506)
Primary outcomes (3)
- measure
- Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.
- timeFrame
- Up to 6 months
- measure
- Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
- timeFrame
- Up to 6 months
- measure
- Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients who are treated with Regorafenib/ STIVARGA and meet the product label. Exclusion Criteria: * Patients who are treated with Regorafenib/ STIVARGA and don't meet the product label.
References
Publications (2)
- DERIVEDKomatsu Y, Muro K, Chosa M, Hirano K, Sunaya T, Ayukawa K, Hattori K, Nishida T. Large-scale, prospective observational study of regorafenib in Japanese patients with advanced gastrointestinal stromal tumors in a real-world clinical setting. Front Oncol. 2024 Jun 17;14:1412144. doi: 10.3389/fonc.2024.1412144. eCollection 2024. PMID 38952554
- DERIVEDKomatsu Y, Doi T, Sawaki A, Kanda T, Yamada Y, Kuss I, Demetri GD, Nishida T. Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 2015 Feb 6. PMID 25655899