Clinical trial · Interventional
Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
NCT00555672CI-TRIAL-00005954completedPhase 1Results postedClinicalTrials.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 purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced 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 |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: 5-fluorouracil
- Drug: cisplatin
- Drug: sunitinib malate
Primary outcomes (1)
- measure
- Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
- timeFrame
- Cycle 1 (Baseline to Day 21)
- description
- The incidence of DLTs assessed during the first cycle (21 days).
Secondary outcomes (10)
- measure
- Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * confirmed diagnosis of stomach cancer * advanced stomach cancer stage IV * adequate blood chemistry, blood counts and kidney function * willing to participate to study requirements and to sign an informed consent document Exclusion Criteria: * prior chemotherapy for stomach cancer in its advanced stage * excessive toxicities related to prior therapies * pregnant or breastfeeding patients
References
Publications (0)
Data not yet available
No reference posted for this study.