Sunitinib in Metastatic Renal Cancer

Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01034878

Enrollment

Registered

2009-12-18

Start date

2009-12-31

Completion date

2014-12-31

Last updated

2014-12-23

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

Conditions

Carcinoma, Renal Cell

Brief summary

Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC patients.

Detailed description

This is a prospective, open label, multicenter phase II study to evaluate efficacy of Sunitinib (in advanced/metastatic renal cancer with non-clear cell histology (papillary or chromophobe). Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off. Treatment with the study drug will continue until tumor progression or unacceptable toxicity. The planned total sample size for this study is 55 patients. Approximately 10 study sites will be involved.

Interventions

DRUGSunitinib

Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks of treatment followed by 2 weeks without treatment.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically proven diagnosis of metastatic renal cancer with non-clear cell * No previous treatment

Exclusion criteria

* Prior treatment with an antiangiogenetic compound * Symptomatic and/or unstable pre-existing brain metastases * Severe or uncontrolled cardiovascular diseases

Design outcomes

Primary

Measure	Time frame
The antitumor activity in terms of progression free survival	two years

Secondary

Measure	Time frame
To evaluate the objective response rate	two years
To evaluate the toxicity and the safety profile	two years
To evaluate the overall survival	two years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026