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Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma

2011年8月25日 更新者：Pfizer

A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma

To assess the maximum tolerated dose and overall safety and tolerability of sunitinib [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

42

段階

  • フェーズ2
  • フェーズ 1

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

  • アメリカ
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48109
        • Pfizer Investigational Site
    • New York
      • New York、New York、アメリカ、10021
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19111-2497
        • Pfizer Investigational Site

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:

  • Histologically confirmed renal cell carcinoma with metastases
  • Evidence of unidimensionally measurable disease
  • Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC

Exclusion Criteria:

  • RCC without any clear (conventional) cell component
  • History of or known brain metastases
  • Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry

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
実験的：Sunitinib + Gefitinib

Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib

Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib
薬：Gefitinib + Sunitinib
Until disease progression or unacceptable toxicity.
他の名前：
  • Iressa, SU011248, SUTENT

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
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
時間枠：From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to Tumor Response (TTR)
時間枠：From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR). For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. If lesion assessment data included more than 1 date, the first date was used. TTR was calculated as (first event date minus first dose date +1)/7. TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response. Kaplan-Meier method was used.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Duration of Response (DR)
時間枠：From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7. DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR).
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
Time to Tumor Progression (TTP)
時間枠：From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Overall Survival (OS)
時間枠：From start of study treatment until death
OS was defined as the time from date of the first dose of study medication to date of death due to any cause. OS (in weeks) is calculated as (date of death minus first dose date +1)/7. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose had their survival times censored at 1 day. Kaplan-Meier method was used.
From start of study treatment until death
Progression-Free Survival (PFS)
時間枠：From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
Probability of Survival at One Year
時間枠：From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication. Survival rate was estimated using the Kaplan-Meier method.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline
時間枠：Baseline (Cycle 1, Day 1)
Concentration of VEGF at baseline.
Baseline (Cycle 1, Day 1)
VEGF Ratio to Baseline at Each Time Point
時間枠：Baseline to Cycle 3, Day 28 inclusive
VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
Baseline to Cycle 3, Day 28 inclusive
VEGF-C Concentration at Baseline
時間枠：Baseline (Cycle 1, Day 1)
Concentration of VEGF-C at baseline.
Baseline (Cycle 1, Day 1)
VEGF-C Ratio to Baseline at Each Time Point
時間枠：Baseline to Cycle 3, Day 28 inclusive
VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
Baseline to Cycle 3, Day 28 inclusive
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
時間枠：Baseline (Cycle 1, Day 1)
Concentration of sVEGFR2 at baseline.
Baseline (Cycle 1, Day 1)
sVEGFR2 Ratio to Baseline at Each Time Point
時間枠：Baseline to Cycle 3, Day 28 inclusive
sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
Baseline to Cycle 3, Day 28 inclusive
Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline
時間枠：Baseline (Cycle 1, Day 1)
Concentration of sVEGFR3 at baseline.
Baseline (Cycle 1, Day 1)
sVEGFR3 Ratio to Baseline at Each Time Point
時間枠：Baseline to Cycle 3, Day 28 inclusive
sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).
Baseline to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median
時間枠：Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Trough Plasma Concentrations (Ctrough) of Sunitinib
時間枠：prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Ctrough of SU-012662 (Sunitinib's Metabolite)
時間枠：prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Ctrough of Gefitinib
時間枠：prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)

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

Pfizer

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

便利なリンク

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10月1日

一次修了 (実際)

2007年9月1日

研究の完了 (実際)

2008年10月1日

試験登録日

最初に提出

2005年6月8日

QC基準を満たした最初の提出物

2005年6月8日

最初の投稿 (見積もり)

2005年6月9日

学習記録の更新

投稿された最後の更新 (見積もり)

2011年8月29日

QC基準を満たした最後の更新が送信されました

2011年8月25日

最終確認日

2011年8月1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

  • A6181038

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。

がん、腎細胞の臨床試験

  • Sun Yat-sen University
    まだ募集していません
    局所進行子宮頸癌に対するNACTにおけるパクリタキセル、シスプラチンとシンジリマブの併用の有効性と毒性
    子宮頸癌 | 化学療法効果 | ネオアジュバント療法 | Programmed Cell Death 1 Receptor / アンタゴニストと阻害剤
  • National Cancer Institute (NCI)
    積極的、募集していない
    進行性分化型甲状腺がんに対するカボザンチニブ、ニボルマブ、およびイピリムマブの組み合わせ（CaboNivoIpi）の試験
    低分化型甲状腺がん | 難治性分化型甲状腺がん | 難治性甲状腺癌 | 濾胞性バリアント甲状腺乳頭がん | Tall Cell Variant 甲状腺乳頭がん | 分化型甲状腺がん | 甲状腺濾胞癌 | 甲状腺乳頭癌 | 甲状腺腫瘍細胞癌
    アメリカ
  • Adelphi Values LLC
    Blueprint Medicines Corporation
    完了
    全身性肥満細胞症の患者報告アウトカムアンケート
    肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されました
    アメリカ
  • National Cancer Institute (NCI)
    Exelixis
    完了
    難治性甲状腺がん患者の治療におけるカボザンチニブ-S-マレート
    再発甲状腺がん | 低分化型甲状腺がん | ステージ I 甲状腺乳頭癌 | II期の甲状腺乳頭癌 | III期の甲状腺乳頭がん | Tall Cell Variant 甲状腺乳頭がん | ステージ I 甲状腺濾胞癌 | II期甲状腺濾胞がん | III期の甲状腺濾胞がん | ステージ IVA 甲状腺濾胞癌 | ステージ IVA 甲状腺乳頭癌 | ステージ IVB 甲状腺濾胞癌 | ステージ IVB 甲状腺乳頭癌 | IVC 期の甲状腺濾胞がん | IVC 期の甲状腺乳頭がん | 甲状腺腫瘍性濾胞癌
    アメリカ
  • Academic and Community Cancer Research United
    National Cancer Institute (NCI)
    完了
    甲状腺分化がん（DTC）におけるレンバチニブとペムブロリズマブ
    低分化型甲状腺がん | 再発性分化型甲状腺がん | 円柱状細胞バリアント甲状腺乳頭癌 | 濾胞性バリアント甲状腺乳頭がん | 転移性甲状腺濾胞癌 | 転移性甲状腺乳頭癌 | 再発甲状腺濾胞癌 | 再発甲状腺乳頭癌 | ステージ III 分化型甲状腺がん AJCC v7 | ステージ III 甲状腺濾胞癌 AJCC v7 | ステージ III 甲状腺乳頭がん AJCC v7 | ステージ IV 甲状腺濾胞癌 AJCC v7 | ステージ IV 甲状腺乳頭癌 AJCC v7 | ステージ IVA 分化型甲状腺がん AJCC v7 | ステージ IVA 甲状腺濾胞癌 AJCC v7 | ステージ IVA 甲状腺乳頭癌 AJCC v7 | ステージ IVB 分化型甲状腺がん... およびその他の条件
    アメリカ

Gefitinib + Sunitinibの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Kenya

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する