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Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

3 agosto 2011 aggiornato da: Pfizer

A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)

This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.

The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.

Panoramica dello studio

Stato

Completato

Condizioni

Carcinoma, cellule renali

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

317

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- Arkansas
  - Hot Springs, Arkansas, Stati Uniti, 71913
    - Pfizer Investigational Site
  - Little Rock, Arkansas, Stati Uniti, 72205
    - Pfizer Investigational Site
- California
  - Anaheim, California, Stati Uniti, 92807
    - Pfizer Investigational Site
  - Baldwin Park, California, Stati Uniti, 91706
    - Pfizer Investigational Site
  - Bellflower, California, Stati Uniti, 90706
    - Pfizer Investigational Site
  - Duarte, California, Stati Uniti, 91010
    - Pfizer Investigational Site
  - Fontana, California, Stati Uniti, 92335
    - Pfizer Investigational Site
  - Irvine, California, Stati Uniti, 92618
    - Pfizer Investigational Site
  - Los Angeles, California, Stati Uniti, 90095
    - Pfizer Investigational Site
  - Los Angeles, California, Stati Uniti, 90027
    - Pfizer Investigational Site
  - Los Angeles, California, Stati Uniti, 90034
    - Pfizer Investigational Site
  - Panorama City, California, Stati Uniti, 91402
    - Pfizer Investigational Site
  - Riverside, California, Stati Uniti, 92505
    - Pfizer Investigational Site
  - San Diego, California, Stati Uniti, 92108
    - Pfizer Investigational Site
  - San Diego, California, Stati Uniti, 92120
    - Pfizer Investigational Site
  - Woodland Hills, California, Stati Uniti, 91365
    - Pfizer Investigational Site
- Colorado
  - Aurora, Colorado, Stati Uniti, 80012
    - Pfizer Investigational Site
  - Boulder, Colorado, Stati Uniti, 80304
    - Pfizer Investigational Site
  - Boulder, Colorado, Stati Uniti, 80303
    - Pfizer Investigational Site
  - Colorado Springs, Colorado, Stati Uniti, 80909
    - Pfizer Investigational Site
  - Denver, Colorado, Stati Uniti, 80220
    - Pfizer Investigational Site
  - Denver, Colorado, Stati Uniti, 80218
    - Pfizer Investigational Site
  - Lakewood, Colorado, Stati Uniti, 80228
    - Pfizer Investigational Site
  - Littleton, Colorado, Stati Uniti, 80120
    - Pfizer Investigational Site
  - Lone Tree, Colorado, Stati Uniti, 80124
    - Pfizer Investigational Site
  - Longmont, Colorado, Stati Uniti, 80501
    - Pfizer Investigational Site
  - Parker, Colorado, Stati Uniti, 80138
    - Pfizer Investigational Site
  - Pueblo, Colorado, Stati Uniti, 81008
    - Pfizer Investigational Site
  - Thorton, Colorado, Stati Uniti, 80260
    - Pfizer Investigational Site
- Connecticut
  - Norwich, Connecticut, Stati Uniti, 06360
    - Pfizer Investigational Site
- Delaware
  - Newark, Delaware, Stati Uniti, 19718
    - Pfizer Investigational Site
  - Newark, Delaware, Stati Uniti, 19713
    - Pfizer Investigational Site
  - Wilmington, Delaware, Stati Uniti, 19899
    - Pfizer Investigational Site
- Florida
  - Boca Raton, Florida, Stati Uniti, 33486
    - Pfizer Investigational Site
  - Delray Beach, Florida, Stati Uniti, 33484
    - Pfizer Investigational Site
  - Lakeland, Florida, Stati Uniti, 33805
    - Pfizer Investigational Site
  - Orlando, Florida, Stati Uniti, 32806
    - Pfizer Investigational Site
- Georgia
  - Columbus, Georgia, Stati Uniti, 31902
    - Pfizer Investigational Site
  - Columbus, Georgia, Stati Uniti, 31904
    - Pfizer Investigational Site
- Idaho
  - Boise, Idaho, Stati Uniti, 83712
    - Pfizer Investigational Site
- Indiana
  - Elkhart, Indiana, Stati Uniti, 46514
    - Pfizer Investigational Site
  - Jefferson, Indiana, Stati Uniti, 47130
    - Pfizer Investigational Site
  - Kokomo, Indiana, Stati Uniti, 46902-3803
    - Pfizer Investigational Site
  - La Porte, Indiana, Stati Uniti, 46350
    - Pfizer Investigational Site
  - LaPorte, Indiana, Stati Uniti, 46350
    - Pfizer Investigational Site
  - LaPorte, Indiana, Stati Uniti, 46350-5533
    - Pfizer Investigational Site
  - Michigan City, Indiana, Stati Uniti, 46360
    - Pfizer Investigational Site
  - Plymouth, Indiana, Stati Uniti, 46563
    - Pfizer Investigational Site
  - South Bend, Indiana, Stati Uniti, 46601
    - Pfizer Investigational Site
  - South Bend, Indiana, Stati Uniti, 46617
    - Pfizer Investigational Site
- Iowa
  - Cedar Rapids, Iowa, Stati Uniti, 52402
    - Pfizer Investigational Site
- Kentucky
  - Lexington, Kentucky, Stati Uniti, 40536
    - Pfizer Investigational Site
  - Lexington, Kentucky, Stati Uniti, 40536-0293
    - Pfizer Investigational Site
  - Louisville, Kentucky, Stati Uniti, 40202
    - Pfizer Investigational Site
  - Louisville, Kentucky, Stati Uniti, 40217
    - Pfizer Investigational Site
  - Louisville, Kentucky, Stati Uniti, 40207
    - Pfizer Investigational Site
  - Shelbyville, Kentucky, Stati Uniti, 40065
    - Pfizer Investigational Site
- Louisiana
  - Baton Rouge, Louisiana, Stati Uniti, 70809
    - Pfizer Investigational Site
  - Covington, Louisiana, Stati Uniti, 70433
    - Pfizer Investigational Site
  - Gretna, Louisiana, Stati Uniti, 70056
    - Pfizer Investigational Site
  - Marrero, Louisiana, Stati Uniti, 70072
    - Pfizer Investigational Site
  - Metairie, Louisiana, Stati Uniti, 70006
    - Pfizer Investigational Site
  - New Orleans, Louisiana, Stati Uniti, 70115
    - Pfizer Investigational Site
  - Shreveport, Louisiana, Stati Uniti, 71103
    - Pfizer Investigational Site
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21201
    - Pfizer Investigational Site
  - Baltimore, Maryland, Stati Uniti, 21237
    - Pfizer Investigational Site
  - Bethesda, Maryland, Stati Uniti, 20817
    - Pfizer Investigational Site
- Michigan
  - Grand Rapids, Michigan, Stati Uniti, 49503
    - Pfizer Investigational Site
  - Holland, Michigan, Stati Uniti, 49424
    - Pfizer Investigational Site
  - Niles, Michigan, Stati Uniti, 49120
    - Pfizer Investigational Site
  - Saint Joseph, Michigan, Stati Uniti, 49085
    - Pfizer Investigational Site
  - St. Joseph, Michigan, Stati Uniti, 49085
    - Pfizer Investigational Site
  - St. Joseph, Michigan, Stati Uniti, 49085-2112
    - Pfizer Investigational Site
  - St. Joseph, Michigan, Stati Uniti, 49085-2158
    - Pfizer Investigational Site
- Missouri
  - Saint Louis, Missouri, Stati Uniti, 63141
    - Pfizer Investigational Site
  - St. Louis, Missouri, Stati Uniti, 63141
    - Pfizer Investigational Site
  - Washington, Missouri, Stati Uniti, 63090
    - Pfizer Investigational Site
- Nevada
  - Henderson, Nevada, Stati Uniti, 89052
    - Pfizer Investigational Site
  - Las Vegas, Nevada, Stati Uniti, 89128
    - Pfizer Investigational Site
  - Las Vegas, Nevada, Stati Uniti, 89148
    - Pfizer Investigational Site
  - Las Vegas, Nevada, Stati Uniti, 89135
    - Pfizer Investigational Site
  - Las Vegas, Nevada, Stati Uniti, 89169
    - Pfizer Investigational Site
- New Jersey
  - Hackensack, New Jersey, Stati Uniti, 07601
    - Pfizer Investigational Site
- New Mexico
  - Albuquerque, New Mexico, Stati Uniti, 87131-0001
    - Pfizer Investigational Site
  - Farmington, New Mexico, Stati Uniti, 87401-5631
    - Pfizer Investigational Site
- New York
  - Albany, New York, Stati Uniti, 12206
    - Pfizer Investigational Site
  - Albany, New York, Stati Uniti, 12208
    - Pfizer Investigational Site
  - Amsterdam, New York, Stati Uniti, 12010
    - Pfizer Investigational Site
  - Brockport, New York, Stati Uniti, 14420
    - Pfizer Investigational Site
  - Canadaigua, New York, Stati Uniti, 14424
    - Pfizer Investigational Site
  - Geneva, New York, Stati Uniti, 14456
    - Pfizer Investigational Site
  - Hudson, New York, Stati Uniti, 12534
    - Pfizer Investigational Site
  - Latham, New York, Stati Uniti, 12110
    - Pfizer Investigational Site
  - New York, New York, Stati Uniti, 10021
    - Pfizer Investigational Site
  - New York, New York, Stati Uniti, 10032
    - Pfizer Investigational Site
  - New York, New York, Stati Uniti, 10022
    - Pfizer Investigational Site
  - Rexford, New York, Stati Uniti, 12148
    - Pfizer Investigational Site
  - Rochester, New York, Stati Uniti, 14623
    - Pfizer Investigational Site
  - Rochester, New York, Stati Uniti, 14626
    - Pfizer Investigational Site
  - Troy, New York, Stati Uniti, 12180
    - Pfizer Investigational Site
- North Carolina
  - Cary, North Carolina, Stati Uniti, 27518
    - Pfizer Investigational Site
  - Clinton, North Carolina, Stati Uniti, 28328
    - Pfizer Investigational Site
  - Elizabeth City, North Carolina, Stati Uniti, 27909
    - Pfizer Investigational Site
  - Goldsboro, North Carolina, Stati Uniti, 27534
    - Pfizer Investigational Site
  - Hickory, North Carolina, Stati Uniti, 28602
    - Pfizer Investigational Site
  - Raleigh, North Carolina, Stati Uniti, 27607
    - Pfizer Investigational Site
  - Raleigh, North Carolina, Stati Uniti, 27614
    - Pfizer Investigational Site
  - Wilson, North Carolina, Stati Uniti, 27893
    - Pfizer Investigational Site
- Ohio
  - Canton, Ohio, Stati Uniti, 44718
    - Pfizer Investigational Site
  - Columbus, Ohio, Stati Uniti, 43219
    - Pfizer Investigational Site
- Oklahoma
  - Norman, Oklahoma, Stati Uniti, 73071
    - Pfizer Investigational Site
  - Oklahoma City, Oklahoma, Stati Uniti, 73120
    - Pfizer Investigational Site
  - Oklahoma City, Oklahoma, Stati Uniti, 73102
    - Pfizer Investigational Site
  - Oklahoma City, Oklahoma, Stati Uniti, 73109
    - Pfizer Investigational Site
  - Oklahoma City, Oklahoma, Stati Uniti, 73112-4416
    - Pfizer Investigational Site
  - Tulsa, Oklahoma, Stati Uniti, 74133
    - Pfizer Investigational Site
  - Tulsa, Oklahoma, Stati Uniti, 74104
    - Pfizer Investigational Site
  - Tulsa, Oklahoma, Stati Uniti, 74136-1902
    - Pfizer Investigational Site
- Oregon
  - Eugene, Oregon, Stati Uniti, 97401
    - Pfizer Investigational Site
  - Springfield, Oregon, Stati Uniti, 97477
    - Pfizer Investigational Site
- Pennsylvania
  - Dunmore, Pennsylvania, Stati Uniti, 18512-3169
    - Pfizer Investigational Site
  - Lemoyne, Pennsylvania, Stati Uniti, 17043-1440
    - Pfizer Investigational Site
  - Philadelphia, Pennsylvania, Stati Uniti, 19111-2497
    - Pfizer Investigational Site
  - Scranton, Pennsylvania, Stati Uniti, 18508
    - Pfizer Investigational Site
- South Carolina
  - Easley, South Carolina, Stati Uniti, 29640
    - Pfizer Investigational Site
  - Greenville, South Carolina, Stati Uniti, 29615
    - Pfizer Investigational Site
  - Greenville, South Carolina, Stati Uniti, 29605
    - Pfizer Investigational Site
  - Seneca, South Carolina, Stati Uniti, 29672
    - Pfizer Investigational Site
  - Spartanburg, South Carolina, Stati Uniti, 29307
    - Pfizer Investigational Site
- Texas
  - Austin, Texas, Stati Uniti, 78705
    - Pfizer Investigational Site
  - Austin, Texas, Stati Uniti, 78745
    - Pfizer Investigational Site
  - Austin, Texas, Stati Uniti, 78759
    - Pfizer Investigational Site
  - Austin, Texas, Stati Uniti, 78731
    - Pfizer Investigational Site
  - Austin, Texas, Stati Uniti, 78758
    - Pfizer Investigational Site
  - Bedford, Texas, Stati Uniti, 76022
    - Pfizer Investigational Site
  - Corpus Christi, Texas, Stati Uniti, 78463
    - Pfizer Investigational Site
  - Dallas, Texas, Stati Uniti, 75230
    - Pfizer Investigational Site
  - Dallas, Texas, Stati Uniti, 75246
    - Pfizer Investigational Site
  - Fort Worth, Texas, Stati Uniti, 76177
    - Pfizer Investigational Site
  - Georgetown, Texas, Stati Uniti, 78626
    - Pfizer Investigational Site
  - Round Rock, Texas, Stati Uniti, 78681
    - Pfizer Investigational Site
  - San Antonio, Texas, Stati Uniti, 78229
    - Pfizer Investigational Site
  - San Antonio, Texas, Stati Uniti, 78207
    - Pfizer Investigational Site
  - San Antonio, Texas, Stati Uniti, 78217
    - Pfizer Investigational Site
  - San Antonio, Texas, Stati Uniti, 78258
    - Pfizer Investigational Site
  - Tyler, Texas, Stati Uniti, 75702
    - Pfizer Investigational Site
  - Webster, Texas, Stati Uniti, 77598
    - Pfizer Investigational Site
- Utah
  - Salt Lake City, Utah, Stati Uniti, 84112
    - Pfizer Investigational Site
- Virginia
  - Chesapeake, Virginia, Stati Uniti, 23320
    - Pfizer Investigational Site
  - Hampton, Virginia, Stati Uniti, 23666
    - Pfizer Investigational Site
  - Newport News, Virginia, Stati Uniti, 23601
    - Pfizer Investigational Site
  - Newport News, Virginia, Stati Uniti, 23502
    - Pfizer Investigational Site
  - Norfolk, Virginia, Stati Uniti, 23502
    - Pfizer Investigational Site
  - Virginia Beach, Virginia, Stati Uniti, 23456
    - Pfizer Investigational Site
  - Williamsburg, Virginia, Stati Uniti, 23188
    - Pfizer Investigational Site
- Washington
  - Seattle, Washington, Stati Uniti, 98195
    - Pfizer Investigational Site
  - Seattle, Washington, Stati Uniti, 98109
    - Pfizer Investigational Site
- West Virginia
  - Morgantown, West Virginia, Stati Uniti, 26506
    - Pfizer Investigational Site
- Wisconsin
  - Madison, Wisconsin, Stati Uniti, 53792
    - Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
Measurable disease

Exclusion Criteria:

Prior systemic therapy of any kind for advanced renal cell cancer
History of brain metastases
Uncontrolled hypertension

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: UN	Droga: Sunitinib Malate Schedule 4/2 Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
Sperimentale: C	Droga: Sunitinib Malate Continuous Daily Dosing Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model Lasso di tempo: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years	MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.	From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Percentage of Participants With Objective Response (OR) Lasso di tempo: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years	Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.	From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Duration of Response (DR) Lasso di tempo: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years	Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.	From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model Lasso di tempo: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years	MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.	From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Altre misure di risultato

Misura del risultato	Misura Descrizione	Lasso di tempo
Functional Assessment of Cancer Therapy-General (FACT-G) Lasso di tempo: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years	FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.	From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS) Lasso di tempo: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years	FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.	From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

To obtain contact information for a study center near you, click here.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2005

Completamento primario (Effettivo)

1 giugno 2010

Completamento dello studio (Effettivo)

1 giugno 2010

Date di iscrizione allo studio

Primo inviato

20 dicembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

20 dicembre 2005

Primo Inserito (Stima)

21 dicembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

5 settembre 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 agosto 2011

Ultimo verificato

1 agosto 2011

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

A6181065

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Altre misure di risultato

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Pubblicazioni e link utili

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Studia le date principali

Inizio studio

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Stima)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio