Clinical trial · Interventional
Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
NCT00595985CI-TRIAL-00002432terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low response rate, no evidence of PFS or OS improved.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).
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 | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent
- interventionNames
- Drug: sorafenib
Primary outcomes (1)
- measure
- time to progression
- timeFrame
- every six weeks
Secondary outcomes (1)
- measure
- toxicity
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced or metastatic adenocarcinoma of the stomach * ECOG performance scale ≤ 2 * At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan) * Adequate hepatic, renal, heart, and hematologic functions: * platelets\>80 × 109/L * neutrophil\>2.0 × 109/L * serum creatinine ≤ 1.5mg/dl * total bilirubin within upper limit of normal(ULN) * serum transaminase ≤ 2.5 × the ULN Exclusion Criteria: * Pregnant or lactating women * Concurrent cancer * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Neuropathy, brain, or leptomeningeal involvement * Uncontrolled significant comorbid conditions and previous radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.