Sunitinib in Metastatic Renal Cancer

NCT01034878 | Completed Phase 2

• 1 other identifier: ONC-2008-004
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

• The antitumor activity in terms of progression free survival

  two years

Secondary Outcomes (3)

• 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

Study Arms (1)

Sunitinib

EXPERIMENTAL

50 mg once daily 6 weeks cycle 4 weeks on and 2 weeks off

Drug: Sunitinib

Interventions

Sunitinib DRUG

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.

Also known as: Sutent

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinco Humanitas

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 18, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

IT (1)