- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01253668
Brivanib Metastatic Renal Cell Carcinoma
18 marzo 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Terminato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
10
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
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Abramson Cancer Center of the University of Pennsylvania
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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
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
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: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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)
Altri nomi:
Undergo 124I-cG250 PET/CT imaging (correlative studies)
Undergo 1241-cG250 PET/CT imaging (correlative studies)
Correlative studies
correlative studies
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Progression Free Survival (PFS)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Best Overall Response Rated for Each Patients as Assessed by RECIST 1.1 Guidelines
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
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 (Effettivo)
1 novembre 2011
Completamento primario (Effettivo)
1 settembre 2013
Completamento dello studio (Effettivo)
1 settembre 2013
Date di iscrizione allo studio
Primo inviato
30 novembre 2010
Primo inviato che soddisfa i criteri di controllo qualità
2 dicembre 2010
Primo Inserito (Stima)
3 dicembre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 aprile 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 marzo 2021
Ultimo verificato
1 marzo 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urologiche
- Neoplasie urogenitali
- Neoplasie per sede
- Malattie renali
- Malattie urologiche
- Adenocarcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie renali
- Carcinoma, cellule renali
- Carcinoma
- Effetti fisiologici delle droghe
- Fattori immunologici
- Anticorpi
- Anticorpi, monoclonali
Altri numeri di identificazione dello studio
- UPCC 04810
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 .
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