Clinical trial · Interventional
Sorafenib Plus S-1 in Advanced Solid Tumors
An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced 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)
Primary Objective: 1. To define the recommended dose for phase II study of S-1 combined with sorafenib 2. To evaluate the dose-limiting toxicities of the combination therapy Secondary Objectives: 1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy 2. To investigate the impact of genetic polymorphisms of metabolic genes on the PK of sorafenib and S-1, respectively, as well as on the toxicity profile of the combination. 3. To determine the changes of biomarkers between pre- and post-treatments.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1 and Sorafenib
- interventionNames
- Drug: Sorafenib
- Drug: S-1
Primary outcomes (1)
- measure
- Determination of MTD/RD
- timeFrame
- First two cycles
Secondary outcomes (1)
- measure
- Dose-limiting Toxicity
- timeFrame
- First two cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven metastatic or locally advanced malignant solid tumors, which are refractory to current standard systemic treatment. * Have measurable lesion. * 20-75 y/o. * ECOG performance score no more than 2. * Life expectancy \> 12 weeks. * Adequate hematopoietic, hepatic and renal functions. 1. Hemoglobin \> 9.0 g/dl 2. Absolute neutrophil count \> 1,500/mm3 3. Platelet count 100,000/ mm3 4. Total bilirubin \< 1.5 times the upper limit of normal (ULN) 5. ALT and AST \< 2.5 x ULN 6. Serum creatinine \< 1.0 x ULN * Recovery from prior therapy that given \> 4 weeks before enrolment. * No pregnancy and breast-feeding. * Signed informed consent. Exclusion Criteria: * Severe cardiovascular disorders. * Pulmonary fibrosis or interstitial pneumonia. * HIV infection. * Active infection. * Major anti-cancer treatment within 4 weeks of study entry. * Exposure to the current investigational agent before. * Known or suspected allergy to the current investigational agent. * Unable to swallow oral medications. * Substance abuse, medical, psychological or social conditions interfering with the patient's participation or evaluation of the study results. * Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study. * Symptoms of bowel obstruction, malnutrition, splenomegaly. * Receiving active anti-coagulant therapy. * Patients with concurrent CYP 2A6 and/or CYP 3A4 or 3A5 inducers or inhibitors; a minimal of 2 weeks wash-out period required.
References
Publications (0)
Data not yet available