- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00243503
Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
20 juli 2011 uppdaterad av: Pfizer
A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Ottignies, Belgien, 1340
- Pfizer Investigational Site
-
Wilrijk, Belgien, 2610
- Pfizer Investigational Site
-
-
-
-
-
Besancon, Frankrike, 25030
- Pfizer Investigational Site
-
Lyon, Frankrike, 69373
- Pfizer Investigational Site
-
Saint Cloud, Frankrike, 92210
- Pfizer Investigational Site
-
-
-
-
Alabama
-
Montgomery, Alabama, Förenta staterna, 36106
- Pfizer Investigational Site
-
-
Delaware
-
Newark, Delaware, Förenta staterna, 19713
- Pfizer Investigational Site
-
Newark, Delaware, Förenta staterna, 19718-6001
- Pfizer Investigational Site
-
Wilmington, Delaware, Förenta staterna, 19899
- Pfizer Investigational Site
-
-
Florida
-
Fort Lauderdale, Florida, Förenta staterna, 33308
- Pfizer Investigational Site
-
-
Illinois
-
Harvey, Illinois, Förenta staterna, 60426
- Pfizer Investigational Site
-
Tinley Park, Illinois, Förenta staterna, 60477
- Pfizer Investigational Site
-
-
Indiana
-
Munster, Indiana, Förenta staterna, 46321
- Pfizer Investigational Site
-
-
Louisiana
-
Lafayette, Louisiana, Förenta staterna, 70503
- Pfizer Investigational Site
-
New Iberia, Louisiana, Förenta staterna, 70563
- Pfizer Investigational Site
-
-
Mississippi
-
Corinth, Mississippi, Förenta staterna, 38834
- Pfizer Investigational Site
-
Southaven, Mississippi, Förenta staterna, 38671
- Pfizer Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89135
- Pfizer Investigational Site
-
-
New York
-
New York, New York, Förenta staterna, 10021
- Pfizer Investigational Site
-
-
Tennessee
-
Memphis, Tennessee, Förenta staterna, 38104
- Pfizer Investigational Site
-
Memphis, Tennessee, Förenta staterna, 38120
- Pfizer Investigational Site
-
-
-
-
Ontario
-
Toronto, Ontario, Kanada, M4N 3M5
- Pfizer Investigational Site
-
-
Quebec
-
Greenfield Park, Quebec, Kanada, J4V 2H1
- Pfizer Investigational Site
-
Montreal, Quebec, Kanada, H3G 1A4
- Pfizer Investigational Site
-
-
-
-
-
Barcelona, Spanien, 08003
- Pfizer Investigational Site
-
Madrid, Spanien, 28040
- Pfizer Investigational Site
-
Valencia, Spanien, 46010
- Pfizer Investigational Site
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
- HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
- Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.
Exclusion Criteria:
- Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
- Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
- Prior treatment on a SU11248 clinical trial.
- Uncontrolled brain metastases.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: A
|
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen.
Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w).
Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants With Overall Confirmed Objective Disease Response
Tidsram: From start of treatment through 18 months
|
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
A CR was defined as the disappearance of all target and non-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 associated to a non-progressive disease response for the non target lesions.
|
From start of treatment through 18 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Duration of Response (DR)
Tidsram: From start of treatment through 18 months
|
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause.
If tumor progression data included more than 1 date, the first date was used.
DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.
|
From start of treatment through 18 months
|
Percentage of Participants With Clinical Benefit
Tidsram: From start of treatment through 18 months
|
Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.
|
From start of treatment through 18 months
|
Progression Free Survival (PFS)
Tidsram: From start of treatment through 18 months
|
Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first.
If tumor progression data included more than 1 date, the first date was used.
PFS was calculated as (first event date minus first dose date +1) divided by 7.
|
From start of treatment through 18 months
|
Time to Progression (TTP)
Tidsram: From start of treatment through 18 months
|
Time from first dose of study treatment to first documentation of objective tumor progression.
If tumor progression data included more than 1 date, the first date was used.
TTP was calculated as (first event date minus first dose date +1) divided by 7.
|
From start of treatment through 18 months
|
Overall Survival (OS)
Tidsram: From start of study treatment until death or 2 years from first study treatment
|
Time from first dose of study treatment to first documentation of death due to any cause.
OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33.
|
From start of study treatment until death or 2 years from first study treatment
|
Probability of Survival at One Year
Tidsram: From start of study treatment until death or 2 years from first study treatment
|
One- year survival probability was estimated using the Kaplan-Meier method.
|
From start of study treatment until death or 2 years from first study treatment
|
EORTC QLQ-C30
Tidsram: From start of treatment through 18 months
|
EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).
Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent.
Scales/single-items averaged, score 0 to 100.
Higher functional/global=better functioning and symptom=greater degree of symptoms.
|
From start of treatment through 18 months
|
EORTC QLQ (BR23)
Tidsram: From start of treatment through 18 months
|
BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast.
Recall period: past week; response range: not at all to very much.
Scale score range: 0 to 100.
Higher symptom score = greater degree of symptoms.
|
From start of treatment through 18 months
|
Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib
Tidsram: Predose on Day 1 of Cycle 3 and 5
|
Ctrough = the concentration prior to study drug administration.
Dose-corrected values were reported, the reference dose was 37.5 mg.
|
Predose on Day 1 of Cycle 3 and 5
|
Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
Tidsram: Predose on Day 1 of Cycle 3 and 5
|
Ctrough = the concentration prior to study drug administration.
Dose-corrected values were reported, the reference dose was 37.5 mg.
|
Predose on Day 1 of Cycle 3 and 5
|
Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Tidsram: Predose on Day 1 of Cycle 3 and 5
|
Ctrough = the concentration prior to study drug administration.
Dose-corrected values were reported, the reference dose was 37.5 mg.
|
Predose on Day 1 of Cycle 3 and 5
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2006
Primärt slutförande (Faktisk)
1 april 2009
Avslutad studie (Faktisk)
1 juli 2010
Studieregistreringsdatum
Först inskickad
20 oktober 2005
Först inskickad som uppfyllde QC-kriterierna
20 oktober 2005
Första postat (Uppskatta)
24 oktober 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
22 juli 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2011
Senast verifierad
1 juli 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Bröstsjukdomar
- Bröstneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Proteinkinashämmare
- Trastuzumab
- Sunitinib
Andra studie-ID-nummer
- A6181067
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Bröstneoplasmer
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital och andra samarbetspartnersAvslutadDen kliniska tillämpningsguiden för Conebeam Breast CTKina
-
ETOP IBCSG Partners FoundationAvslutadBreast Cancer Invasive NosItalien
-
Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAvslutadBreast Cancer Invasive NosSpanien
-
Pomeranian Medical University SzczecinMaria Sklodowska-Curie National Research Institute of Oncology; Regional...OkändBRCA1-mutation | Breast Cancer Invasive NosPolen
-
University Health Network, TorontoAvslutadBreast Cancer Invasive Nos | Primär invasiv bröstcancerKanada
-
Novartis PharmaceuticalsAvslutadMetastaserad bröstcancer (MBC) | Locally Advance Breast Cancer (LABC)Storbritannien, Spanien
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)AvslutadMetastatisk malign neoplasm | Ooperbar malign neoplasm | Avancerad malign neoplasmFörenta staterna
-
Massachusetts General HospitalRekryteringMalign neoplasm | Benign neoplasmFörenta staterna
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, inte rekryterandeMetastatisk malign neoplasm | Avancerad malign neoplasm | Återkommande malign neoplasm | Refraktär malign neoplasm | Lokalt avancerad malign neoplasmFörenta staterna
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, inte rekryterandeMalign neoplasm | Metastatisk malign neoplasm | Avancerad malign neoplasm | Återkommande malign neoplasm | Lokalt avancerad malign neoplasmFörenta staterna
Kliniska prövningar på SU011248/Trastuzumab
-
H. Lee Moffitt Cancer Center and Research InstitutePfizerAvslutadLeiomyosarkom | Fibrosarkom | Liposarkom | Malignt fibröst histiocytomFörenta staterna
-
National Cancer Institute (NCI)NRG OncologyAktiv, inte rekryterandeDuktalt bröstkarcinom på platsFörenta staterna, Kanada, Puerto Rico, Korea, Republiken av
-
PfizerAvslutadNeoplasmer i levern | Ooperabelt hepatocellulärt karcinomKorea, Republiken av, Taiwan, Frankrike
-
Tony Bekaii-SaabPfizerAvslutadMatstrupscancerFörenta staterna
-
Tanvex BioPharma USA, Inc.AvslutadBröstcancer | Bröstneoplasmer | HER2-positiv bröstcancer | Steg II Bröstcancer | Steg IIIA Bröstcancer | Bröstcancer i ett tidigt stadiumBelarus, Chile, Georgien, Ungern, Indien, Mexiko, Peru, Filippinerna, Ryska Federationen, Ukraina
-
AGO Study GroupPhilipps University Marburg Medical Center; HSK Reasearch GmbH WiesbadenAvslutadPlatina eldfast epitelial äggstockscancer | Primär cancer i bukhinnan | Cancer i äggledarenTyskland
-
Spanish Breast Cancer Research GroupAvslutad
-
Fudan UniversityHoffmann-La RocheOkänd
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRekryteringHER2-positiv bröstcancer | Bröstcancer i ett tidigt stadium | Adjuvansbehandling efter Trastuzumab | RCB-klassificering 1-2 | NeratiniKina
-
Duke UniversityPfizerAvslutad