A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Small Cell Lung Cancer or Other Non-Hematological Malignancies
調査の概要
研究の種類
入学 (実際)
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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Arizona
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Peoria、Arizona、アメリカ、85381
- Site Reference ID/Investigator# 13605
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Phoenix、Arizona、アメリカ、85013
- Site Reference ID/Investigator# 5261
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California
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Los Angeles、California、アメリカ、90095-7187
- Site Reference ID/Investigator# 11942
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Sacramento、California、アメリカ、95817
- Site Reference ID/Investigator# 4718
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Colorado
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Aurora、Colorado、アメリカ、80045-0510
- Site Reference ID/Investigator# 3755
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Site Reference ID/Investigator# 8324
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Illinois
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Chicago、Illinois、アメリカ、60612
- Site Reference ID/Investigator# 2623
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Maryland
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Baltimore、Maryland、アメリカ、21231-1000
- Site Reference ID/Investigator# 2625
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Bethesda、Maryland、アメリカ、20892
- Site Reference ID/Investigator# 12343
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Site Reference ID/Investigator# 11941
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Boston、Massachusetts、アメリカ、02215
- Site Reference ID/Investigator# 2626
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North Carolina
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Charlotte、North Carolina、アメリカ、28204
- Site Reference ID/Investigator# 4934
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- Site Reference ID/Investigator# 2624
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Washington
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Tacoma、Washington、アメリカ、98405
- Site Reference ID/Investigator# 6650
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Leicester、イギリス、LE1 5WW
- Site Reference ID/Investigator# 18541
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Manchester、イギリス、M20 4BX
- Site Reference ID/Investigator# 2622
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Edmonton、カナダ、T6G 1Z2
- Site Reference ID/Investigator# 7493
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Ottawa、カナダ、K1H 8L6
- Site Reference ID/Investigator# 7635
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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:
- The subject must be >=18 years of age.(Phase 1 & 2a)
- Histologically and/or cytologically documented diagnosis of small cell lung cancer (North America & UK) or other non-hematological malignancy (North America only).(Phase 1 only)
- Histologically and/or cytologically documented diagnosis of SCLC.(Phase 2a)
- At least one prior chemotherapy treatment regimen(s) and their disease is refractory or experienced progressive disease following the treatment.(Phase 1)
- Extensive-stage SCLC & is chemotherapy naïve(US only) has experienced progressive disease following at least one chemotherapy regimen or their disease is refractory.(Phase 2a)
- Brain metastases with clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function & no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
- ECOG performance score <= 2(Ph 1) <=1(Phase 2a)
- Must be receiving a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants 21 days prior to 1st dose of study drug.
Adequate bone marrow, renal & hepatic function per local lab reference range at Screening as follows:
- Bone marrow: Absolute Neutrophil count (ANC)>=1000/µL
- Platelets>= 100,000/mm3
- Hemoglobin>=9.0g/dL
- Renal function: Serum creatinine<= 2.0mg/dL or calculated creatinine clearance>=50mL/min
- Hepatic function&enzymes: AST and ALT<=3.0 x the upper normal limit(ULN) of institution's normal range
- Bilirubin<=1.5xULN. If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
- Coagulation: aPTT and PT<=1.2 x the upper limit of normal
- Should have archived diagnostic tissue available for assessment of Bcl-2 family protein expression.(Phase 2a)
- All female subjects not surgically sterile or postmenopausal(for at least 1 year)and non-vasectomized male subject must practice at least one method of birth control.
Exclusion Criteria:
- Underlying or predisposing condition of bleeding or currently exhibits signs of bleeding.
- Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug.
- Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
- The subject has active immune thrombocytopenic purpura (ITP),active autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
- Currently receiving or requires anticoagulation therapy or any drug or herbal supplements that affect platelet function, with exception of low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter.
- Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy (ERT), anti estrogen analogs, agonists required to suppress serum testosterone levels), or any investigational therapy within 14 days prior to the first dose of study drug, or has not recovered to less than a grade 2 adverse effect(s) of the previous therapy.
- Received a biologic (G-CSF, GM-CSF or erythropoietin) within 28 days prior to the first dose of study drug.
- Steroid therapy for anti-neoplastic intent within seven days prior to the first dose of study drug.
- Has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
- Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
- Positive for HIV
A history of other active malignancies within the past 3 years prior to screening, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri
- Basal or squamous cell carcinoma of the skin
- Previous malignancy confined and surgically resected with curative intent
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Active systemic fungal infection
- Diagnosis of fever and neutropenia within 1 week prior to study drug administration.
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: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:Phase 1 and Phase 2a
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Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study. Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 40 patients with SCLC |
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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Safety assessment
時間枠:Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Dose limiting toxicity determination
時間枠:Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Maximum tolerated dose determination
時間枠:Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Pharmacokinetic profile evaluation
時間枠:Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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二次結果の測定
結果測定 |
時間枠 |
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Extended safety assessment at the recommended Phase 2 dose
時間枠:Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Preliminary efficacy assessment
時間枠:Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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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
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。
ABT-263の臨床試験
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Kathleen Ludwig利用可能
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National Cancer Institute (NCI)終了しました難治性悪性固形新生物 | 再発悪性固形新生物 | 転移性悪性固形新生物 | 切除不能固形腫瘍 | 再発性肺小細胞がん | ステージ IIIA 肺小細胞がん AJCC v7 | ステージ IIIB 肺小細胞がん AJCC v7 | ステージ IV 肺小細胞がん AJCC v7 | ステージ III 肺小細胞癌、米国癌合同委員会 (AJCC) v7アメリカ
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City of Hope Medical CenterNational Cancer Institute (NCI)募集
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National Cancer Institute (NCI)積極的、募集していないステージ IIIA 肺非小細胞がん AJCC v7 | 進行性肺非扁平上皮非小細胞がん | 転移性肺非扁平上皮非小細胞がん | ステージ IIIB 肺非小細胞がん AJCC v7 | ステージ IV 肺非小細胞がん AJCC v7 | ステージ III 肺非小細胞がん AJCC v7アメリカ
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AbbVie積極的、募集していない骨髄線維症 (MF)アメリカ, アルゼンチン, オーストラリア, ブラジル, ブルガリア, チリ, ハンガリー, イスラエル, イタリア, 日本, 大韓民国, スペイン, スウェーデン, 七面鳥
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AbbVie終了しました
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AbbVie (prior sponsor, Abbott)完了
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AbbVie積極的、募集していない骨髄線維症 (MF)アメリカ, オーストラリア, オーストリア, ベルギー, ブルガリア, カナダ, クロアチア, フランス, ドイツ, ギリシャ, イスラエル, イタリア, 日本, 大韓民国, オランダ, ニュージーランド, ロシア連邦, セルビア, 南アフリカ, スペイン, スウェーデン, 台湾, 七面鳥, ウクライナ, イギリス