NCT00943839

Brief Summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2015

Enrollment Period

5.8 years

First QC Date

July 21, 2009

Last Update Submit

November 9, 2016

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Outcome Measures

Primary Outcomes (2)

  • Disease response

    5 years

  • VEGF and IL-8 blood levels determined before and every 6 weeks during treatment

    5 years

Secondary Outcomes (3)

  • Length of the response

    up to 5 years

  • Disease-free survival

    up to 5 years

  • Overall survival

    up to 5 years

Study Arms (1)

SUVEGIL

EXPERIMENTAL
Drug: sunitinib malateOther: laboratory biomarker analysisOther: pharmacological study

Interventions

sunitinib malateDRUG
SUVEGIL
laboratory biomarker analysisOTHER
SUVEGIL
pharmacological studyOTHER
SUVEGIL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Metastatic disease requiring first-line treatment with sunitinib malate * No prior therapy for metastatic disease * No symptomatic or uncontrolled cerebral metastasis PATIENT CHARACTERISTICS: * Affiliation to the French Social insurance * Life expectancy ≥ 3 months * No heart failure * No chronic unstable disease * No long QT interval * No history of another primary cancer * No severe, uncontrolled acute infection * No severe, uncontrolled hypertension * No psychological disorder PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (2)

  • Montemagno C, Durivault J, Gastaldi C, Dufies M, Vial V, He X, Ambrosetti D, Kamenskaya A, Negrier S, Bernhard JC, Borchiellini D, Cao Y, Pages G. A group of novel VEGF splice variants as alternative therapeutic targets in renal cell carcinoma. Mol Oncol. 2023 Jul;17(7):1379-1401. doi: 10.1002/1878-0261.13401. Epub 2023 Apr 18.

    PMID: 36810959DERIVED

  • Polena H, Creuzet J, Dufies M, Sidibe A, Khalil-Mgharbel A, Salomon A, Deroux A, Quesada JL, Roelants C, Filhol O, Cochet C, Blanc E, Ferlay-Segura C, Borchiellini D, Ferrero JM, Escudier B, Negrier S, Pages G, Vilgrain I. The tyrosine-kinase inhibitor sunitinib targets vascular endothelial (VE)-cadherin: a marker of response to antitumoural treatment in metastatic renal cell carcinoma. Br J Cancer. 2018 May;118(9):1179-1188. doi: 10.1038/s41416-018-0054-5. Epub 2018 Mar 22.

    PMID: 29563634DERIVED

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jean Marc Ferrero, MD

    Centre Antoine Lacassagne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 22, 2009

Study Start

February 1, 2009

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

November 10, 2016

Record last verified: 2015-11

Locations

FR(1)