- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00651482
Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus)
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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California
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Stanford, California, Spojené státy, 94305
- Stanford University School of Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Signed Informed Consent Form
- Histologically confirmed metastatic RCC that is predominantly clear cell Measurable disease, as defined by RECIST
- Age ≥ 18 years
- ECOG performance status of 0 or 1
- No more than 1 prior targeted therapy (eg, sorafenib, sunitinib) (prior cytokine therapy allowed)
- No more than 2 prior systemic therapies
- Ability and capacity to comply with the study and follow-up procedures
General Exclusion Criteria
- Inability to comply with study and/or follow-up procedures
- Life expectancy of < 12 weeks
Inadequate organ function, as evidenced by any of the following at screening:
- Absolute neutrophil count (ANC) < 1500/uL
- Platelet count ≤ 100 x 10^9/L
- Total bilirubin ≥ 1.5 x upper limit of normal (ULN)
- AST and/or ALT > 2.5 x ULN for patients without evidence of liver metastases, or 5 x ULN for patients with documented liver metastases
- Serum creatinine > 2.0 mg/dL
- Hemoglobin < 9 g/dL (may be transfused or receive epoetin alfa to maintain or exceed this level)
- Active infection or fever > 38.5°C within 3 days of starting treatment
- Women who are pregnant or breast feeding,
- Able to conceive and unwilling to practice an effective method of birth control.
- History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
- Malignancies that have undergone a putative surgical cure (i.e., localized prostate cancer post-prostatectomy) within 5 years prior to Day 1 may be discussed with the Principal Investigator.
- Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results.
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
Disease-Specific Exclusion Criteria
- RCC with predominantly sarcomatoid features
- Radiotherapy for RCC within 28 days prior to Day 1, with the exception of single-fraction radiotherapy given for the indication of pain control
- Prior treatment with bevacizumab or any mTOR inhibitor (eg, temsirolimus, sirolimus, or everolimus)
- Current need for dialysis
Bevacizumab-Specific Exclusions
- Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
- Significant vascular disease (eg, aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy that is not intentionally pharmacologically-induced
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening as demonstrated by a urine protein:
- Creatinine (UPC) ratio ≥ 1.0. If UPC ratio ≥ 1.0, the patient must undergo a 24 hour urine collection which must demonstrate ≤ 1g of protein in 24 hours to be eligible.
- Known hypersensitivity to any component of bevacizumab
RAD001-Specific Exclusion Criteria
- Known hypersensitivity to any component of RAD001
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- Severely impaired lung function (spirometry and DLCO < 50% of normal and O2 saturation 88% or less at rest on room air)
- If O2 saturation is ≤ 88% at rest on screening, pulmonary function tests (PFTs) will be ordered to confirm normal pulmonary function and eligibility.
- Fasting total cholesterol > 350 mg/dL
- Fasting triglyceride level > 400 mg/dL or >2.5 x ULN
- Fasting serum glucose > 250 mg/dL
- Serum phosphorus < 2.0 mg/dL
- Serum corrected calcium < 8.0 mg/dL
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Bevacizumab + RAD001 (everolimus)
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted) Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability) |
Ostatní jména:
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Progression-free Survival (PFS)
Časové okno: 24 months
|
Progression-free survival (PFS) per RECIST criteria
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24 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Objective Response (OR)
Časové okno: 24 months
|
Number of subjects with objective response (OR)
|
24 months
|
Objective Response (OR) Duration
Časové okno: 24 months
|
24 months
|
|
Time-to-Treatment Failure (TTF)
Časové okno: 24 months
|
24 months
|
|
Overall Survival (OS)
Časové okno: 44 months
|
44 months
|
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Number of Subjects With Drug-related SAEs
Časové okno: 24 months
|
24 months
|
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Total Number of Drug-related SAEs
Časové okno: 24 months
|
24 months
|
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Treatment Discontinuation Due to Toxicity
Časové okno: 24 months
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Number of subjects whose treatment was discontinued due to toxicity
|
24 months
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Treatment Discontinuation Due to Disease Progression
Časové okno: 24 months
|
Number of subjects whose treatment was discontinued due to disease progression
|
24 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle histologického typu
- Novotvary
- Urologické novotvary
- Urogenitální novotvary
- Novotvary podle místa
- Onemocnění ledvin
- Urologická onemocnění
- Adenokarcinom
- Karcinom
- Novotvary, žlázové a epiteliální
- Novotvary ledvin
- Karcinom, renální buňka
- Fyziologické účinky léků
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Antineoplastická činidla, Imunologická
- Inhibitory angiogeneze
- Činidla modulující angiogenezi
- Růstové látky
- Inhibitory růstu
- Bevacizumab
- Everolimus
Další identifikační čísla studie
- IRB-11789
- RENAL0016 (Jiný identifikátor: OnCore)
- 98593 (Jiný identifikátor: Stanford University Alternate IRB Approval Number)
- AVF4304s (Jiný identifikátor: Genentech-Roche)
- 41839 (Jiný identifikátor: Novartis, Inc)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .