NCT00338884

Brief Summary

A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Geographic Reach
6 countries

15 active sites

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

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 14, 2011

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

2.6 years

First QC Date

June 16, 2006

Results QC Date

April 20, 2010

Last Update Submit

August 22, 2012

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Overall Confirmed Objective Response (OR)

    OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting \> = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

    From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter

Secondary Outcomes (28)

  • Duration of Response (DR)

    From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause

  • Time to Tumor Progression (TTP)

    From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter

  • Progression-Free Survival (PFS)

    From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death

  • 1-Year Survival

    From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year

  • Trough Plasma Concentrations (Ctrough) of Sunitinib

    Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

  • +23 more secondary outcomes

Study Arms (1)

SUNITINIB MALATE.

EXPERIMENTAL

Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Drug: Sunitinib malate

Interventions

Sunitinib malateDRUG

Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

SUNITINIB MALATE.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced kidney cancer

You may not qualify if:

  • Previous treatment for kidney cancer, except surgical removal of kidney tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Pfizer Investigational Site

Córdoba, Córdoba Province, X5000AAI, Argentina

Location

Pfizer Investigational Site

Rosario, Santa Fe Province, (2000), Argentina

Location

Pfizer Investigational Site

Buenos Aires, 1431, Argentina

Location

Pfizer Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Pfizer Investigational Site

Clayton, Victoria, 3168, Australia

Location

Pfizer Investigational Site

East Bentleigh, Victoria, 3165, Australia

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01308-050, Brazil

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44280, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Taichung, 407, Taiwan

Location

Pfizer Investigational Site

Tainan, 710, Taiwan

Location

Pfizer Investigational Site

Taipei, 112, Taiwan

Location

Related Publications (4)

  • de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

    PMID: 28410911DERIVED

  • Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

    PMID: 27238653DERIVED

  • Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

    PMID: 25577718DERIVED

  • Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6.

    PMID: 21898376DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 31, 2012

Results First Posted

June 14, 2011

Record last verified: 2012-08

Locations

TW(3)BR(2)AR(3)AU(3)ME(2)KR(2)