NCT00077974

Brief Summary

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2004

Typical duration for phase_2

Geographic Reach
1 country

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

Study Start

First participant enrolled

February 1, 2004

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2004

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 3, 2009

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

4.6 years

First QC Date

February 13, 2004

Results QC Date

September 25, 2009

Last Update Submit

October 8, 2010

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)

    Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as \>= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

    From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

Secondary Outcomes (11)

  • Time to Tumor Progression (TTP)

    From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

  • Duration of Response (DR)

    Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer

  • Overall Survival (OS)

    From start of study treatment until death

  • Progression-free Survival (PFS)

    From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death

  • Percent Chance of Patient Survival

    From start of study treatment until death

  • +6 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: SU011248

Interventions

SU011248DRUG

50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity

Also known as: Sunitinib, SUTENT
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cytokine refractory metastatic renal cell carcinoma with clear cell component
  • Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
  • Prior nephrectomy

You may not qualify if:

  • Prior treatment with any systemic therapy other than 1 cytokine therapy
  • History of or known brain metastases
  • Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Pfizer Investigational Site

Duarte, California, 91010-3000, United States

Location

Pfizer Investigational Site

Pasadena, California, 91105, United States

Location

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Rochester, Minnesota, 55905, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

New York, New York, 10022, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27705, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97213, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

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

  • Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.

    PMID: 16757724DERIVED

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.govCallCenter@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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2004

First Posted

February 18, 2004

Study Start

February 1, 2004

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 13, 2010

Results First Posted

November 3, 2009

Record last verified: 2010-10

Locations

US(15)