Clinical trial · Interventional
Study of Sunitinib Administered as 4/2 vs. 2/1 Schedule in Advanced Renal Cell Carcinoma (RCC)
A Randomized Phase II Trial Of Sunitinib Administered Daily For 4 Weeks, Followed By 2-Week Rest Vs. 2-Week On And 1-Week Off In Metastatic Renal Cell Carcinoma
NCT00570882CI-TRIAL-00015694completedPhase 2ClinicalTrials.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 evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.
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 |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sunitinib 4/2
- description
- Sunitinib 50 mg PO 4-week on and 2-week off
- interventionNames
- Drug: Sunitinib 4/2
- type
- EXPERIMENTAL
- label
- Sunitinib 2/1
- description
- Sunitinib 50 mg PO 2-week on 1-week off
- interventionNames
- Drug: Sunitinib 2/1
Primary outcomes (1)
- measure
- Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmation of renal cell carcinoma with a clear cell histologic component 2. Patients must present with stage IV disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent. 3. Measurable disease according to RECIST criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study 4. ECOG performance status 2 or better 5. Age 18 years or older 6. Adequate bone marrow, hepatic, and renal function 7. Life expectancy of \> 3 months 8. Singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment Exclusion Criteria: 1. Known spinal cord compression or carcinomatous meningitis 2. Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri 3. Hypertension that cannot be controlled by medications (blood pressure \> 150/90 mmHg despite optimal medical therapy) 4. Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day). 5. Pregnancy or breast feeding. 6. Other severe acute or chronic medical or psychiatric condition 7. Prior treatment on sunitinib, sorafenib, or bevacizumab.
References
Publications (1)
- DERIVEDLee JL, Kim MK, Park I, Ahn JH, Lee DH, Ryoo HM, Song C, Hong B, Hong JH, Ahn H. RandomizEd phase II trial of Sunitinib four weeks on and two weeks off versus Two weeks on and One week off in metastatic clear-cell type REnal cell carcinoma: RESTORE trial. Ann Oncol. 2015 Nov;26(11):2300-5. doi: 10.1093/annonc/mdv357. Epub 2015 Sep 7. PMID 26347107