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- Klinische proef NCT01253668
Brivanib Metastatic Renal Cell Carcinoma
18 maart 2021 bijgewerkt door: Abramson Cancer Center of the University of Pennsylvania
Brivanib (BMS-582664, Brivanib Alaninate) in Treatment of Refractory Metastatic Renal Cell Carcinoma - A Phase II Pharmacodynamic and Baseline Biomarker Study
This is a phase II study of an investigational agent, brivanib, in patients with refractory metastatic renal cell carcinoma.
This study will evaluate the safety and effectiveness of brivanib in renal cell carcinoma, and explore the activity of this drug in this population to determine whether imaging and molecular features of the tumors can be used to predict response.
Approximately 30 people with advanced kidney cancer will be enrolled on this study at the University of Pennsylvania.
Studie Overzicht
Toestand
Beëindigd
Conditie
Gedetailleerde beschrijving
The primary objective of this clinical trial is to determine the efficacy of brivanib in the treatment of metastatic renal cell carcinoma in terms of progression-free survival (PFS) in patients who have progressed on treatment with sunitinib, sorafenib, bevacizumab, or pazopanib.
The primary endpoint of the trial will be PFS at 16 weeks.
The secondary objectives are to further examine the safety and tolerability profile of brivanib, to examine the efficacy of brivanib in this population in terms of best overall response, response rate, progression-free survival, and overall survival, to describe baseline and changes in I-cG250 PET/CT in relation to observed therapeutic effects, to describe novel baseline histologic features of these tumors in relation to observed therapeutic effects.
Modalities will include Von Hippel-Lindau gene (VHL) and hypoxia-inducible factor 1 gene (HIF-1) expression assessment and a novel histo-cytometric assessment of the tumor microenvironment in terms of p-STAT3, p-ERK, Ki67, VEGFR2, FGFR1 expression, to describe changes in circulating collagen IV on brivanib in relation to therapeutic effects, to explore the relationship between single nucleotide polymorphisms in angiogenesis-related genes and the activity of brivanib in the treatment of these patients.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
10
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Male and female adults with metastatic renal cell carcinoma
- Patients will have tumors that bear a clear cell component that comprises greater than or equal to 50% of the tumor.
- Disease must be measurable in accord with RECIST 1.1 guidelines.
- Patients who have developed progressive disease or intolerance on treatment with sorafenib, sunitinib, bevacizumab, or pazopanib over a 60 day period who have not discontinued this therapy more than 100 days prior to study enrollment. Progressive disease per RECIST 1.1 guidelines will be preferred
- Therapy with up to three prior systemic regimens will be allowed.
- Patients may have been treated with any of the following: sorafenib, sunitinib, bevacizumab, pazopanib, temsirolimus, everolimus, interferon alpha, interleuken-2.
- Treatment with up to one prior regimen that included cytotoxic chemotherapy will be allowed.
- Patients may have been treated with more than 1 antiangiogenic therapy (e.g., patients may have been treated with both sorafenib and sunitinib or sunitinib and bevacizumab, or sequential combinations that include pazopanib).
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Tumor tissue must be available for correlative studies.
- Patients must consent to allow the acquisition of formalin-fixed paraffin-embedded (FFPE) material (block or unstained slides) by study personnel for performance of correlative tissue studies.
Exclusion Criteria:
- Known brain metastases
- Prior therapy with brivanib, or anti-FGFR (fibroblast growth factor receptor) therapy.
- History of thrombotic or embolic events within the last six months such as a cerebrovascular accident (including transient ischemic attacks), pulmonary embolism.
- Gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE version 4.0 Grade greater than 3 within 30 days prior to study entry.
- Uncontrolled or significant cardiovascular disease.
- QTc greater than 450 msec on two consecutive ECGs (Baseline ECG should be repeated if QTc is found to be greater than 450 msec.).
- Active infection, less than 7 days after completing systemic antibiotic therapy.
- History of non-healing wounds or ulcers or bone fractures within 3 months of fracture.
- Major surgical procedure, open biopsy, or significant traumatic injury less than 3 weeks prior to study enrollment or those who receive minor surgical procedures (e.g. core biopsy or fine needle aspiration)within 1 week prior to study enrollment.
- Cytotoxic chemotherapy within 3 weeks, bevacizumab within 2 months, or radiation therapy within 2 weeks, other targeted therapies (e.g., sorafenib, sunitinib, temsirolimus, everolimus)within 2 days.
- Inability to swallow tablets or untreated malabsorption syndrome.
- Pre-existing thyroid abnormality with thyroid function that cannot be controlled with medication.
- History of HIV
- Patients with centrally cavitating lung lesions.
- Patients requiring therapeutic anticoagulation with warfarin at baseline. However, prophylactic therapy with a low molecular weight heparin at baseline is acceptable.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Arm 1
Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.
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Brivanib by mouth daily at a dose of 800mg.
Undergo 1241-cG250 PET/CT imaging (correlative studies)
Andere namen:
Undergo 124I-cG250 PET/CT imaging (correlative studies)
Undergo 1241-cG250 PET/CT imaging (correlative studies)
Correlative studies
correlative studies
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Progression Free Survival (PFS)
Tijdsspanne: 16 weeks
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All patients will be followed through the entire 16-week period and will be given a binary outcome assignment: progressive disease or not.
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16 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Best Overall Response Rated for Each Patients as Assessed by RECIST 1.1 Guidelines
Tijdsspanne: Every 8 weeks
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The best overall radiographic response to therapy as measured and assessed using RECIST 1.1 guidelines will be captured for each research subject.
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Every 8 weeks
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Overall Survival
Tijdsspanne: Every 8 weeks
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Will record deaths on study, and, to the extent possible, after the study follow-up period is completed for each patient, will be captured.
Reason for death will be identified and recorded where possible.
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Every 8 weeks
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Change in Total Antibody Binding as Assessed by 124I-cG250 PET/CT Imaging (Correlative Studies)
Tijdsspanne: At baseline and 8 weeks
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Will determine the baseline and change in total antibody binding in lesions from baseline to the time on treatment that patients are assessed.
The analysis dataset will be quantitated radiotracer uptake data obtained via I-cG250 PET/CT for all evaluable patients who complete the trial.
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At baseline and 8 weeks
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Response Rate for All Patients
Tijdsspanne: Every 8 weeks
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Response Rate for all patients as assessed by RECIST 1.1 guidelines
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Every 8 weeks
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Molecular Markers
Tijdsspanne: At baseline
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Molecular markers expressed in patient tumor specimens as assessed by IHC and histocytometry (e.g., VHL, HIF, p-STAT3, p-ERK, and Ki67, VEGFR2, and FGFR1) (correlative studies)
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At baseline
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Changes in Collagen IV Levels
Tijdsspanne: At baseline and week 3
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Changes in collagen IV levels for each patient (correlative studies)
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At baseline and week 3
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Germline Polymorphisms and Assessment of Relationship to Toxicity and Clinical Outcome
Tijdsspanne: At baseline and week 3
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Germline polymorphisms and assessment of relationship to toxicity and clinical outcome (correlative studies)
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At baseline and week 3
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Blood Pressure Data
Tijdsspanne: At baseline, day 1 weeks 3,6,8,12,16 and every 6-8 weeks thereafter
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Blood pressure data
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At baseline, day 1 weeks 3,6,8,12,16 and every 6-8 weeks thereafter
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Toxicity as Assessed by NCI CTCAE Version 4.0
Tijdsspanne: Day 1, weeks 3,6,9,12,16, and every 6-8 weeks thereafter
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Toxicity as assessed by NCI CTCAE version 4.0
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Day 1, weeks 3,6,9,12,16, and every 6-8 weeks thereafter
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 november 2011
Primaire voltooiing (Werkelijk)
1 september 2013
Studie voltooiing (Werkelijk)
1 september 2013
Studieregistratiedata
Eerst ingediend
30 november 2010
Eerst ingediend dat voldeed aan de QC-criteria
2 december 2010
Eerst geplaatst (Schatting)
3 december 2010
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 april 2021
Laatste update ingediend die voldeed aan QC-criteria
18 maart 2021
Laatst geverifieerd
1 maart 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Urologische neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Nier Ziekten
- Urologische ziekten
- Adenocarcinoom
- Neoplasmata, glandulair en epitheel
- Nierneoplasmata
- Carcinoom, niercel
- Carcinoom
- Fysiologische effecten van medicijnen
- Immunologische factoren
- Antilichamen
- Antilichamen, monoklonaal
Andere studie-ID-nummers
- UPCC 04810
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Bing HanVoltooidPure Red Cell Aplasia, verworvenChina
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Klinische onderzoeken op Brivanib alaninate
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Bristol-Myers SquibbVoltooidHepatocellulair carcinoomVerenigde Staten, Argentinië, Australië, Canada, China, Frankrijk, Hongkong, Italië, Japan, Korea, republiek van, Taiwan, Thailand, Spanje
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Bristol-Myers SquibbVoltooid
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Bristol-Myers SquibbVoltooidWekedelensarcoom | Overgangscelcarcinoom | Geavanceerde niet-kleincellige longkanker | Adenocarcinoom van de maag/slokdarm | Pancreaskanker inclusief Ampulla van VaterVerenigde Staten, Argentinië, Duitsland, België, Canada, Polen, Nederland, Verenigd Koninkrijk, Frankrijk
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Bristol-Myers SquibbVoltooidNeoplasma metastase | TumorenItalië, Verenigd Koninkrijk, Verenigde Staten, Canada
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Zai Lab (Shanghai) Co., Ltd.VoltooidHepatocellulair carcinoom (HCC)China
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Gynecologic Oncology GroupNational Cancer Institute (NCI)VoltooidCervicaal adenocarcinoom | Cervicaal adenosquameus carcinoom | Cervicaal plaveiselcelcarcinoom, niet anders gespecificeerd | Recidiverend cervicaal carcinoom | Aanhoudende ziekteVerenigde Staten
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Bristol-Myers SquibbVoltooidCarcinoom, hepatocellulairVerenigde Staten, Spanje
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Bristol-Myers SquibbVoltooidLeverkankerVerenigde Staten, Argentinië, Brazilië, Canada, China, Frankrijk, Duitsland, Hongkong, Indië, Italië, Japan, Korea, republiek van, Mexico, Puerto Rico, Russische Federatie, Taiwan, Spanje, België, Griekenland
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Gynecologic Oncology GroupNational Cancer Institute (NCI)VoltooidRecidiverend Baarmoedercorpuscarcinoom | Endometrium Clear Cell Adenocarcinoom | Endometrium sereus adenocarcinoom | Endometrium ongedifferentieerd carcinoom | Endometrium Adenocarcinoom | Endometrium overgangscelcarcinoom | Endometrium slijmvlies adenocarcinoom | Endometrium gemengd adenocarcinoom en andere voorwaardenVerenigde Staten
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Bristol-Myers SquibbVoltooidHepatocellulair carcinoom (HCC)Frankrijk, Korea, republiek van, Taiwan, Verenigde Staten, Singapore, Filippijnen, Maleisië, Hongkong