Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus)
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Stanford、California、アメリカ、94305
- Stanford University School of Medicine
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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) |
他の名前:
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Progression-free Survival (PFS)
時間枠:24 months
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Progression-free survival (PFS) per RECIST criteria
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24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Objective Response (OR)
時間枠:24 months
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Number of subjects with objective response (OR)
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24 months
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Objective Response (OR) Duration
時間枠:24 months
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24 months
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Time-to-Treatment Failure (TTF)
時間枠:24 months
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24 months
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Overall Survival (OS)
時間枠:44 months
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44 months
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Number of Subjects With Drug-related SAEs
時間枠:24 months
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24 months
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Total Number of Drug-related SAEs
時間枠:24 months
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24 months
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Treatment Discontinuation Due to Toxicity
時間枠:24 months
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Number of subjects whose treatment was discontinued due to toxicity
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24 months
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Treatment Discontinuation Due to Disease Progression
時間枠:24 months
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Number of subjects whose treatment was discontinued due to disease progression
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24 months
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-11789
- RENAL0016 (その他の識別子:OnCore)
- 98593 (その他の識別子:Stanford University Alternate IRB Approval Number)
- AVF4304s (その他の識別子:Genentech-Roche)
- 41839 (その他の識別子:Novartis, Inc)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
エベロリムスの臨床試験
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Concept Medical Inc.積極的、募集していない冠動脈疾患 | 糖尿病 | 急性冠症候群スイス, オーストラリア, 大韓民国, フランス, ベルギー, オランダ, イギリス, インド, オーストリア, バングラデシュ, ブラジル, チェコ, ドイツ, アイルランド, イタリア, マレーシア, メキシコ, ポーランド, シンガポール, スウェーデン, 台湾
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National Taiwan University Hospitalわからない