Study of ABT-869 in Subjects With Advanced Renal Cell Carcinoma Who Have Previously Received Treatment With Sunitinib
2. januar 2013 opdateret af: AbbVie (prior sponsor, Abbott)
An Open-Label, Phase 2 Study to Evaluate the Efficacy and Tolerability of ABT-869 in Subjects With Advanced Renal Cell Carcinoma (RCC) Who Have Previously Received Treatment With Sunitinib
This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the treatment of subjects with advanced renal cell carcinoma who have previously received treatment with sunitinib.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
53
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Vancouver, Canada, V5Z 4E6
- Site Reference ID/Investigator# 6566
-
-
-
-
California
-
Sacramento, California, Forenede Stater, 95817
- Site Reference ID/Investigator# 7193
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20010
- Site Reference ID/Investigator# 5243
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60637
- Site Reference ID/Investigator# 5384
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Site Reference ID/Investigator# 11662
-
Boston, Massachusetts, Forenede Stater, 02114
- Site Reference ID/Investigator# 11663
-
Boston, Massachusetts, Forenede Stater, 02114
- Site Reference ID/Investigator# 5379
-
-
New Hampshire
-
Lebanon, New Hampshire, Forenede Stater, 03756-0001
- Site Reference ID/Investigator# 5380
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19111
- Site Reference ID/Investigator# 5249
-
Philadelphia, Pennsylvania, Forenede Stater, 19111
- Site Reference ID/Investigator# 6278
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- Site Reference ID/Investigator# 6269
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Site Reference ID/Investigator# 7300
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030-4009
- Site Reference ID/Investigator# 6796
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria
- Subject has undergone previous nephrectomy.
- Subject has received at least 2 cycles (12 weeks) of treatment with sunitinib for RCC and stopped therapy due to progressive disease within 100 days prior to screening.
- Subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST.
- ECOG Performance Score of 0-1.
- No history of another active cancer within the past 5 years.Life expectancy of at least 4 months.
- Willing to take adequate measures to prevent pregnancy.
Exclusion Criteria
- Subject has received anti-cancer therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration.
- Subject has untreated brain or meningeal metastases.
- Subject has received a tyrosine kinase inhibitor (TKI) other than sunitinib or sorafenib.
- Prior use of Avastin is allowed.
- The subject is receiving therapeutic anticoagulation therapy.
- The subject has a history of/or currently exhibits clinically significant cancer related events of bleeding (e.g., hematuria, hemoptysis).
- The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 100 mmHg; or systolic blood pressure (BP) > 150 mmHg.
- The subject has a history of myocardial infarction within 6 months of Study Day 1.
- The subject has a documented left ventricular (LV) Ejection Fraction < 50%.
- The subject has known autoimmune disease with renal involvement (eg, Lupus).
- Female subjects who are pregnant or breast feeding.
- Subject is receiving anti-retroviral therapy for HIV.
Subject has a clinically significant uncontrolled condition(s) including but not limited to:
- active uncontrolled infection,
- Class III or IV heart failure as defined by the New York Heart Association functional classification system,
- unstable angina pectoris or cardiac arrhythmia,
- history of adrenal insufficiency,
- psychiatric illness/social situation that would limit compliance with study requirements;
- Active, ulcerative colitis, Crohn's disease, celiadisease or any other conditions that interfere with absorption.
- Subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Single arm
One oral dose daily
|
One oral dose daily.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Objective Response Rate
Tidsramme: From randomization until patient death or alive at 2 years
|
From randomization until patient death or alive at 2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Progression-free rate
Tidsramme: Week 16
|
Week 16
|
|
Best response rate
Tidsramme: From randomization until patient death or alive at 2 years
|
From randomization until patient death or alive at 2 years
|
|
Time to tumor progression
Tidsramme: From randomization until patient death or alive at 2 years
|
From randomization until patient death or alive at 2 years
|
|
Progression free survival
Tidsramme: Radiographic evaluation every month, clinical evaluation every 4 weeks
|
Radiographic evaluation every month, clinical evaluation every 4 weeks
|
|
Overall Survival
Tidsramme: Two-year follow-up post study
|
Two-year follow-up post study
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2007
Primær færdiggørelse (Faktiske)
1. juni 2011
Studieafslutning (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først indsendt
12. juni 2007
Først indsendt, der opfyldte QC-kriterier
12. juni 2007
Først opslået (Skøn)
14. juni 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. januar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M06-882
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .