Clinical trial · Interventional
Sorafenib Gastric Cancer Asian Phase I Study
Phase I Study to Investigate Safety, Pharmacokinetics and Preliminary Efficacy Profile of Sorafenib (BAY 43-9006) in Combination With S-1 Plus CDDP in Asian Patients With Unresectable / Recurrent Gastric Cancer
NCT00663741CI-TRIAL-00010678completedPhase 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 investigate safety, pharmacokinetics and preliminary efficacy profile of sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable / recurrent gastric cancer.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
- type
- EXPERIMENTAL
- label
- Arm 2
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
- type
- EXPERIMENTAL
- label
- Arm 3
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological confirmation of the primary unresectable or recurrent gastric cancer (both with and without measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) are allowed). Peritoneal dissemination without ascites is allowed. * No prior systemic anticancer therapy including chemotherapy, immunotherapy, targeted agents or experimental therapies for advanced disease * Prior adjuvant therapy/neo adjuvant therapy is allowed if recurrence occurred 6 months after completion of these therapies * Age \>/= 18 years and \< 75 years Exclusion Criteria: * Known brain metastasis, spinal cord compression or meningeal carcinomatosis. * Clinically relevant ascites * Concurrent cancer that is distinct in primary site or histology from gastric cancer * Any condition that impairs patient's ability to swallow whole pills
References
Publications (0)
Data not yet available
No reference posted for this study.