A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
2010年10月8日 更新者：Pfizer
A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
調査の概要
研究の種類
介入
入学 (実際)
106
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Duarte、California、アメリカ、91010-3000
- Pfizer Investigational Site
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Pasadena、California、アメリカ、91105
- Pfizer Investigational Site
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San Francisco、California、アメリカ、94115
- Pfizer Investigational Site
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Pfizer Investigational Site
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Boston、Massachusetts、アメリカ、02115
- Pfizer Investigational Site
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Boston、Massachusetts、アメリカ、02215
- Pfizer Investigational Site
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- Pfizer Investigational Site
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Pfizer Investigational Site
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New York
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New York、New York、アメリカ、10021
- Pfizer Investigational Site
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New York、New York、アメリカ、10022
- Pfizer Investigational Site
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North Carolina
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Durham、North Carolina、アメリカ、27705
- Pfizer Investigational Site
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Pfizer Investigational Site
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Oregon
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Portland、Oregon、アメリカ、97213
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19111
- Pfizer Investigational Site
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- Pfizer Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Cytokine refractory metastatic renal cell carcinoma with clear cell component
- Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
- Prior nephrectomy
Exclusion Criteria:
- Prior treatment with any systemic therapy other than 1 cytokine therapy
- History of or known brain metastases
- Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：非ランダム化
- 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：1
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50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
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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Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
時間枠：From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST.
CR defined as disappearance of all target lesions.
PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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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 |
|---|---|---|
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Time to Tumor Progression (TTP)
時間枠：From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first.
TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Duration of Response (DR)
時間枠：Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
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Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of patients with a confirmed objective tumor response. |
Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
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Overall Survival (OS)
時間枠：From start of study treatment until death
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Time in weeks from the start of study treatment to date of death due to any cause.
OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).
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From start of study treatment until death
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Progression-free Survival (PFS)
時間枠：From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
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Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause.
PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
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Percent Chance of Patient Survival
時間枠：From start of study treatment until death
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Probability of survival 1 year and 2 years after the first dose of study treatment
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From start of study treatment until death
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Observed Plasma Trough Concentrations of Sunitinib
時間枠：Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) (Cmin) concentrations of sunitinib
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed Plasma Trough Concentrations of Sunitinib Metabolite
時間枠：Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
時間枠：Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib
時間枠：Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib.
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
時間枠：Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662).
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
時間枠：Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662).
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
- Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
- Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
- Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2004年2月1日
一次修了 (実際)
2008年9月1日
研究の完了 (実際)
2008年9月1日
試験登録日
最初に提出
2004年2月13日
QC基準を満たした最初の提出物
2004年2月17日
最初の投稿 (見積もり)
2004年2月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2010年10月13日
QC基準を満たした最後の更新が送信されました
2010年10月8日
最終確認日
2010年10月1日
詳しくは
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。