Clinical trial · Interventional
A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
NCT02626754CI-TRIAL-00033435terminatedPhase 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): In most sites had difficult to recruitting subjects.
Summary
Brief summary (as posted)
This is a multi-national, phase II, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell carcinoma.
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib
- description
- Sunitinib malate, 12.5mg/capsule, 50mg/day
- interventionNames
- Drug: Sunitinib malate
Primary outcomes (1)
- measure
- Incidence of treatment-emergent adverse events (safety and tolerability)
- timeFrame
- 24 months
- description
- To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma
Secondary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced renal cell carcinoma with histology confirmation * Grade III/IV AEs happen during first cycle of sunitinib 50mg/day 4 weeks on followed by 2 weeks of rest * ECOG performance status 0 or 1 * Appropriate vital organ functions Exclusion Criteria: * Prior systemic treatment of mRCC * Patients treated with any neoadjuvant or adjuvant systemic therapy * Major surgery \<4 weeks or radiation therapy \<2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated * Pregnant * Allergic history to sunitinib
References
Publications (0)
Data not yet available
No reference posted for this study.