A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes
This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) will receive investigational study drug ARRY-614.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 50 patients from the US will be enrolled in Part 1 (Completed).
In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Completed).
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Florida
-
Tampa、Florida、アメリカ、33612
- Moffitt Cancer Center
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30322
- Emory University, Winship Cancer Institute
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic
-
-
Texas
-
Houston、Texas、アメリカ、77030
- MD Anderson Cancer Center
-
-
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
Key Inclusion Criteria (Part 1 and Part 2):
- Diagnosis of MDS by bone marrow biopsy.
- International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.
- May have received prior therapy for MDS.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Adequate liver and renal function.
- Additional criteria exist.
Key Exclusion Criteria (Part 1 and Part 2):
- History of bone marrow transplant.
- Treatment for MDS other than transfusions or a stable dose (≥ 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug.
- Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.
- Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have prolonged side effects.
- Treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug.
- Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to > 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug.
- Treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug.
- Additional criteria exist.
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 |
|---|---|
|
実験的：ARRY-614
|
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule
|
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 |
時間枠 |
|---|---|
|
Establish the maximum tolerated dose (MTD) of study drug.
時間枠：Part 1, 9 months
|
Part 1, 9 months
|
|
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
時間枠：Part 1, 9 months; Part 2, 9 months
|
Part 1, 9 months; Part 2, 9 months
|
|
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
時間枠：Part 1, 9 months; Part 2, 9 months
|
Part 1, 9 months; Part 2, 9 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Assess the efficacy of the study drug in terms of response, time to response, duration of response, overall survival, hematologic improvement and platelet transfusion independence/reduction.
時間枠：Part 1, 9 months; Part 2, 9 months
|
Part 1, 9 months; Part 2, 9 months
|
協力者と研究者
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 (実際)
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
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。