Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone in Multiple Myeloma (ACY-1215)
A Phase 1/2, Open-Label, Multicenter Study of ACY-1215 Administered Orally as Monotherapy and in Combination With Bortezomib and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma
Phase 1(a & b): To evaluate the side effects and determine the best dose of oral ACY-1215 as monotherapy, and also in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Winship Cancer Institute, Emory University
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Massachusetts General Hospital
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New York
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New York、New York、アメリカ、10029
- Mt. Sinai Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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Texas
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Houston、Texas、アメリカ、77030
- MD Anderson Cancer Center
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin - Clinical Cancer Center
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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:
Patient has relapsed or relapsed/refractory MM with measurable disease parameters according to the International Myeloma Working Group (IMWG) Criteria
- Refractory is defined as experiencing less than minimal response (MR) to or progressive disease (PD) within 60 days after completion of the most recent anti-MM regimen
- Relapsed is defined as experiencing PD that requires therapy but which is not refractory following the achievement of stable disease (SD) or better to the most recent anti-MM regimen.
- Patient received at least 2 prior regimens for MM.
- Patient received prior treatment for MM with a proteasome inhibitor and an immunomodulatory drug, unless not a candidate for a proteasome inhibitor or an immunomodulatory drug.
- Patient either is not a candidate for autologous stem cell transplant (ASCT), has declined the option of ASCT, or has relapsed after prior ASCT.
- Patient is ≥18 years of age.
- Patient has a Karnofsky Performance Status score of ≥70
Patient has adequate bone marrow reserve, as evidenced by:
- Absolute neutrophil count (ANC) of ≥1.0x109/L.
- Platelet count of ≥ 75x109/L in patients in whom <50% of bone marrow nucleated cells are plasma cells and ≥50x109/L in patients in whom more than 50% of bone marrow nucleated cells are plasma cells.
- Patient has adequate renal function (calculated creatinine clearance of ≥30 mL/min according to the Cockroft-Gault)
- Patient has adequate hepatic function (serum bilirubin values <2.0 mg/dL and ALT and/or AST values <3 × the upper limit of normal ULN).
- Patient has a corrected serum calcium ≤ULN.
Exclusion Criteria
Patient has received any of the following therapies:
- Radiotherapy or systemic therapy within 2 weeks of baseline
- Prior peripheral autologous stem cell transplant within 12 wks of Baseline.
- Prior allogeneic stem cell transplant.
- Prior treatment with an HDAC inhibitor.
- Patient has an active systemic infection requiring treatment.
- Patient has a history of other malignancies unless has undergone definitive treatment more than 5 yrs prior to study and without evidence of recurrent malignant disease (excluding basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/mL; or cervical intraepithelial neoplasia).
- Patient has known or suspected HIV, positive for hepatitis B or is known or suspected to have active hepatitis C infection.
- Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness including recent myocardial infarction (within 6 months)or stroke; hypertension requiring >2 medications for adequate control; diabetes mellitus with >2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive pulmonary disease (COPD) requiring >2 hospitalizations in the preceding 12 months.
- Patient has a QTcF value of >480 msec; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy; previous history of drug-induced QTc prolongation
- Patient has > Grade 2 painful neuropathy or peripheral neuropathy
- Patient has a history of allergic reaction attributable to bortezomib or other compounds containing boron or mannitol (Phase 1b and 2a only)
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:Treat Regimen
ACY-1215 Bortezomib Dexamethasone
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Liquid oral dose on Days 1-5 and 8-12 of 21-day treatment cycle
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 |
時間枠 |
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Phase 1 (a & b): To determine the maximum tolerated dose of ACY-1215 as monotherapy or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
時間枠:Upon completion of 21-day treatment cycle
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Upon completion of 21-day treatment cycle
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Phase 2a: To determine the objective response rate to ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
時間枠:Assessed every other treatment cycle (cycles 2, 4 and 6)
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Assessed every other treatment cycle (cycles 2, 4 and 6)
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二次結果の測定
結果測定 |
時間枠 |
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Characterize the safety of ACY-1215 alone or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma
時間枠:Up to 24 weeks
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Up to 24 weeks
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Determine the single- and multiple-dose PK of ACY-1215 alone and in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma
時間枠:Upon completion of 21 day treatment cycle
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Upon completion of 21 day treatment cycle
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Evaluate the pharmacodynamics of ACY-1215 alone or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
時間枠:Up to 24 weeks.
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Up to 24 weeks.
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Sagar Lonial, MD、Winship Cancer Institute, Emory University
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
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。
ACY-1215の臨床試験
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Jennifer AmengualAcetylon Pharmaceuticals Incorporated完了
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Dana-Farber Cancer InstituteAcetylon Pharmaceuticals Incorporated積極的、募集していない
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Columbia UniversityNational Cancer Institute (NCI); Acetylon Pharmaceuticals Incorporated完了
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National Institute of Allergy and Infectious Diseases...Moderna TX, Inc積極的、募集していない
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Mayo ClinicNational Cancer Institute (NCI)引きこもった切除不能な肝外胆管癌 | 再発胆管がん | 切除不能な胆管癌 | III期肝内胆管がん | IIIA期の肺門胆管がん | IIIB期の肺門胆管がん | IVA 期の肺門胆管癌 | IVA期の肝内胆管がん | IVB期の肺門胆管がん | IVB期の肝内胆管がん | III期肝外胆管がん | IVA期の肝外胆管がん | IVB期の肝外胆管がんアメリカ
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Dana-Farber Cancer InstituteCelgene Corporation終了しました