NCT00083889 is a Phase 3 clinical trial of Interferon-alfa in Carcinoma, Renal Cell, sponsored by Pfizer.

Who is sponsoring NCT00083889?

NCT00083889 is sponsored by Pfizer.

What drugs are being tested in NCT00083889?

Interventions in NCT00083889: Interferon-alfa, SU011248.

What condition does NCT00083889 study?

NCT00083889 studies Carcinoma, Renal Cell.

Is NCT00083889 still recruiting?

NCT00083889 is currently completed. Last updated 19 January 2010.

Are results published for NCT00083889?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2010-01-19 · How we verify

NCT00083889

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

Completed Phase 3 Results posted Last updated 19 January 2010

What this trial tests

Phase 3 trial testing Interferon-alfa in Carcinoma, Renal Cell in 750 participants. Completed in 1 September 2008.

Timeline

1 August 2004

Primary endpoint
1 September 2008

1 September 2008

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	750
Start date	1 August 2004
Primary completion	1 September 2008
Estimated completion	1 September 2008
Sites	123 locations across United States, Australia, Brazil, Canada, France, Germany, Italy, Poland

Drugs / interventions tested

Interferon-alfa
SU011248 — full drug profile →

Conditions studied

Carcinoma, Renal Cell — all drugs for Carcinoma, Renal Cell →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Renal Cell. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Progression-Free Survival (PFS), Core Radiology Assessment
Time frame: Day 28 of each 6-week cycle: duration of treatment phase
Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.
Progression-Free Survival (PFS), Investigator's Assessment
Time frame: Day 28 of each 6-week cycle: duration of treatment phase
Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.

Sponsor's own description

The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Sunitinib versus interferon alfa in metastatic renal-cell carcinoma.
Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, et al · · 2007 · cited 4182× · PMID 17215529 · DOI 10.1056/nejmoa065044
Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma.
Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, et al · · 2009 · cited 1583× · PMID 19487381 · DOI 10.1200/jco.2008.20.1293
Antiangiogenic therapy: impact on invasion, disease progression, and metastasis.
Ebos JM, Kerbel RS. · · 2011 · cited 540× · PMID 21364524 · DOI 10.1038/nrclinonc.2011.21
Recent advances on anti-angiogenesis receptor tyrosine kinase inhibitors in cancer therapy.
Qin S, Li A, Yi M, Yu S, et al · · 2019 · cited 221× · PMID 30866992 · DOI 10.1186/s13045-019-0718-5
Body Mass Index and Metastatic Renal Cell Carcinoma: Clinical and Biological Correlations.
Albiges L, Hakimi AA, Xie W, McKay RR, et al · · 2016 · cited 165× · PMID 27601543 · DOI 10.1200/jco.2016.66.7311
Angiotensin system inhibitors and survival outcomes in patients with metastatic renal cell carcinoma.
McKay RR, Rodriguez GE, Lin X, Kaymakcalan MD, et al · · 2015 · cited 103× · PMID 25724518 · DOI 10.1158/1078-0432.ccr-14-2332
Prognostic factors for survival in 1059 patients treated with sunitinib for metastatic renal cell carcinoma.
Motzer RJ, Escudier B, Bukowski R, Rini BI, et al · · 2013 · cited 102× · PMID 23695024 · DOI 10.1038/bjc.2013.236
Clinical Application of Cytokines in Cancer Immunotherapy.
Qiu Y, Su M, Liu L, Tang Y, et al · · 2021 · cited 76× · PMID 34079226 · DOI 10.2147/dddt.s308578

Verify or expand the search:

Other recruiting trials for Carcinoma, Renal Cell

Currently open trials in the same condition.

NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
NCT07227415 — Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Antica · Phase 1, PHASE2 · recruiting
NCT06222593 — Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant · Phase 1, PHASE2 · recruiting
NCT07166445 — Deep Learning for Automated Discrimination Between Stage T1-T2 and T3 Renal Cell Carcinoma on Contrast-Enhanced CT · recruiting
NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00083889 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 19 January 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00083889.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing