A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
2016年2月11日 更新者：Synta Pharmaceuticals Corp.
A Non-randomized, Open Label, Multi-center Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Patients With Metastatic and/or Unresectable GIST Resistant or Refractory to Prior Systemic Treatments Including Imatinib and Sunitinib
The purpose of this study is to determine if STA-9090 is effective in the treatment of patients with metastatic and/or unresectable GIST.
調査の概要
詳細な説明
Planned:
- Stage 1: 23 patients. If ≥4 patients had clinical benefit, an additional 32 patients were to be enrolled. Up to 3 additional patients with platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) mutation were to be enrolled, regardless of the total study enrollment.
- Stage 2: 55 patients. Progressing to this stage was dependent on Stage 1 results.
Analyzed:
- Stage 1: 27 patients were enrolled and analyzed. The study was not expanded to Stage 2 due to insufficient efficacy.
研究の種類
介入
入学 (実際)
27
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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Los Angeles、California、アメリカ、90095
- UCLA Medical Center
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Dana Farber Cancer Institute
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Oregon
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Portland、Oregon、アメリカ、97239
- Oregon Health and Science University-Knight Cancer Institute
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19111-2497
- Fox Chase Cancer Center
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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:
- Must be at least 18 years of age at the time of study entry
- Must have histologically confirmed metastatic and/or unresectable GIST
- Must have measurable disease on computed tomography or magnetic resonance imaging as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Must have documented failure (due to either progression or intolerance)of at least prior imatinib and sunitinib. Previous administration of other known heat shock protein 90 (Hsp90) inhibitors is permitted
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Must have acceptable laboratory values as defined in the protocol
Exclusion Criteria:
- Known central nervous system metastases
- Major surgery within 4 weeks prior to receiving STA-9090
- Use of any investigational agents within 2 weeks or 6 half-lives of the agent, whichever is shorter prior to receiving STA-9090
- No treatment with chronic immunosuppressants
- Must have otherwise adequate health status as defined in the protocol
- Left ventricular ejection fraction (LVEF) < than or = 50% at baseline
- Baseline corrected QT interval (QTc) > 470 msec
- Pregnant or lactating females
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：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：ganetespib 200 mg/m^2
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle).
Treatment continues until disease progression or unacceptable toxicity.
|
Ganetespib 200 mg/m^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week.
Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of 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 |
|---|---|---|
|
Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
時間枠：Week 16 up to Week 47
|
Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.
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Week 16 up to Week 47
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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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Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0
時間枠：Week 16 up to Week 47
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Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.
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Week 16 up to Week 47
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Kaplan-Meier Estimate of Progression Free Survival (PFS)
時間枠：Day 1 up to Week 47
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PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as
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Day 1 up to Week 47
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Kaplan-Meier Estimate of Overall Survival
時間枠：Day 1 up to week 97
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Overall survival was defined as the time from first dose to death or the date last known alive.
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Day 1 up to week 97
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Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)
時間枠：Day 2 to Day 10
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PET imaging was completed on selected patients only from one investigative site.
Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10.
PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines [Young H, Eur J Cancer, 1999].
Tumor response was considered a complete response (CR) or a partial response (PR).
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Day 2 to Day 10
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Count of Participants With Treatment-Emergent Adverse Events (AEs)
時間枠：Day 1 up to Week 51
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Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event. Dose modification includes dose delay and dose reduction. |
Day 1 up to Week 51
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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。
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
2010年1月1日
一次修了 (実際)
2011年12月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2009年12月23日
QC基準を満たした最初の提出物
2009年12月24日
最初の投稿 (見積もり)
2009年12月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年3月10日
QC基準を満たした最後の更新が送信されました
2016年2月11日
最終確認日
2016年2月1日
詳しくは
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