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Safety and Efficacy of Sunitinib Given in Schedule Modification in Patients with Advanced Renal Cell Carcinoma (RCC)

Safety and Efficacy of Sunitinib Given in Schedule Modification in Patients with Advanced Renal Cell Carcinoma (RCC) - Study of Sunitinib Given in Schedule Modification in Advanced Renal Cell Carcinoma (RCC)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011649
Enrollment
132
Registered
2013-09-04
Start date
2013-07-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Interventions

Arm of Sunitinib 2-week on/ 1-week off Sunitinib 50 mg/day PO 2 weeks followed by 1 week rest. The patients with Grade 3 and more or required interruption due to investigators judge, are interrupted

Sponsors

Osaka University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: – Histologically confirmation or clinically diagnosis of renal cell carcinoma Measurable disease at least 1 site according to RECIST criteria are required in CT images Life expectancy of > 12 weeks Signed and dated informed consent of document indicating that the patient but representative has been informed of all pertinent aspects of the trial prior to enrollment

Exclusion criteria

Exclusion criteria: Diagnosis of any secondary malignancy Patients who are judged by an investigator to be inappropriate for this study for any other reason

Design outcomes

Primary

MeasureTime frame
Treatment discontinuation rate due to unacceptable toxicities and relative dose intensity within 6 weeks (within 1 course) Duration of treatment and progression free-survival

Secondary

MeasureTime frame
–Objective response rate –Quality of life

Countries

Japan

Contacts

Public ContactMotohide Uemura

Osaka University Graduate School of Medicine Department of Organ Specific Regulation (Urology)

uemura@uro.med.osaka-u.ac.jp81668793531

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026