A Study of LY2875358 in Participants With Advanced Cancer
A Phase 1 Study of LY2875358 in Patients With Advanced Cancer
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究場所
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California
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La Jolla、California、アメリカ、92037-0845
- University of California - San Diego
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Los Angeles、California、アメリカ、90048-5615
- Cedars Sinai Medical Center
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San Francisco、California、アメリカ、94115
- Univ of California San Francisco
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Santa Monica、California、アメリカ、90404
- UCLA
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Florida
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic of Jacksonville
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor、Michigan、アメリカ、48109-0946
- University of Michigan
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Minnesota
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Rochester、Minnesota、アメリカ、55902
- Mayo Clinic
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Thomas Jefferson University
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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:
- Part A: Have histological or cytological evidence of cancer (solid tumor, lymphoma, or multiple myeloma) that is advanced and/or metastatic and an appropriate candidate for experimental therapy
- Part A2: Histologic or cytologic diagnosis of advanced Non Small Cell Lung Cancer (NSCLC), Stage IIIB with malignant pleural effusion or Stage IV, completed at least 1 prior systemic regimen, and eligible for erlotinib therapy.
- Part B: Candidate for experimental therapy after standard therapies used or non-eligible for standard therapies. Histological or cytological evidence of 1 of the 5 tumor types:
Castrate-resistant prostate cancer (CRPC) with bone metastasis:
--Progressive Disease in the setting of castrate level of testosterone
Renal Cell Carcinoma (RCC):
--Histologic diagnosis of either clear-cell or papillary RCC (metastatic and unresectable, or bilateral, multifocal, unresectable RCC localized to kidneys).
NSCLC:
--Histologic or cytologic diagnosis of advanced NSCLC, Stage IIIB with malignant pleural effusion or Stage IV
Hepatocellular Carcinoma (HCC)
--Histologic or cytologic diagnosis of hepatocellular carcinoma
- Uveal Melanoma with liver metastasis
- Part A: Have the presence of measurable or nonmeasurable disease as defined by the RECIST v1.1 (Eisenhauer et al. 2009) or Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) or have measureable disease for multiple myeloma.
- Part A2 & B (RCC, NSCLC, HCC, and uveal melanoma): Have measurable disease as defined by RECIST v1.1.
- Give written informed consent prior to any study-specific procedures.
- Adequate organ function.
- Performance status of less than or equal to 2 on ECOG scale.
- Discontinued all previous cancer therapies, and any agents that have not received regulatory approval, for at least 21 days and recovered from the acute effects of therapy. Must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.
- Reliable and available for the duration of the study and willing to follow study procedures.
- Males and females (reproductive potential): Use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug.
- Females (childbearing potential): Have had a negative serum pregnancy test before the first dose of study drug and not be breast-feeding.
- Estimated life expectancy that will permit the participants to complete 8 weeks of treatment.
Exclusion Criteria:
- Serious preexisting medical conditions
- Symptomatic central nervous system malignancy or metastasis (screening not required).
- Acute or chronic leukemia.
- Active infection including HIV, hepatitis A, B or C
- Have second primary malignancy that may affect the interpretation of results.
- Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C.
- Patients with active alcohol abuse, as determined by the treating investigator.
- Part A2: Unable to swallow tablets. Intolerant of therapy with erlotinib. Concomitant treatment with the cytochrome P450 3A (CYP3A) modulators. Must not have received treatment with any of these modulators within 14 days of study treatment.
- Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction 6 months prior to study drug
- QTc greater than 470 msec.
- Received previous treatment with any c-MET experimental therapeutic.
Part B Expansion Cohort 1 (CRPC):
- Increasing use of daily doses of opioid analgesics within 28 days prior to enrollment in the study.
- Neuroendocrine prostate cancer.
- Patients who have a solitary bone metastasis that has been irradiated are not eligible.
- Part B Expansion Cohort 6 (LY2875358 plus trametinib in participants with uveal melanoma with liver metastasis): Contra-indications for trametinib
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:LY2875358
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Part A Dose escalation of LY2875358 administered intravenously (IV), Day 1 and 15 every 28 days for at least two cycles.
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実験的:LY2875358 + erlotinib
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Part A2 Dose escalation of LY2875358 administered IV, on Day 1 and 15 every 28 days for at least two cycles in combination with daily erlotinib dosing (150 mg) taken orally (PO).
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実験的:LY2875358 at Part A highest dose
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Part B (Dose Exploration): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles.
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実験的:LY2875358 at Part A highest dose + trametinib
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Part B (in combination with trametinib): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles, in combination with trametinib at 2 mg orally once daily
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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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Recommended Phase 2 dose range of LY2875358 monotherapy and in combination with erlotinib
時間枠:Baseline through Cycle 1
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Baseline through Cycle 1
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二次結果の測定
結果測定 |
時間枠 |
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Pharmacokinetics: Maximum plasma concentration (Cmax)
時間枠:Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment
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Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment
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Number of participants with a tumor response
時間枠:Baseline to study completion (12 months)
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Baseline to study completion (12 months)
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Pharmacokinetics: Area under the concentration-time curve (AUC)
時間枠:Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment
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Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment
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Time to progression and overall survival
時間枠:Baseline to study completion (12 months)
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Baseline to study completion (12 months)
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Pharmacokinetics: Area under the concentration-time curve (AUC) of erlotinib or trametinib in combination with LY2875358
時間枠:Cycle 1
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Cycle 1
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Change from baseline in Brief Pain Inventory (BPI) in Part B: Expansion Cohort 1
時間枠:Baseline to study completion (12 months)
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Baseline to study completion (12 months)
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協力者と研究者
スポンサー
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。
進行がんの臨床試験
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Advanced Bionics完了重度から重度の難聴 | Advanced Bionics HiResolution™ Bionic Ear System の成人ユーザーの割合アメリカ
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LY2875358の臨床試験
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Eli Lilly and Company完了
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Eli Lilly and Company完了
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Eli Lilly and Company積極的、募集していないがん、非小細胞肺スペイン, 台湾, イギリス, フランス, ドイツ, オランダ, 大韓民国, イタリア, デンマーク
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Eli Lilly and Company完了がん、非小細胞肺アメリカ, ドイツ, スペイン, ベルギー, フランス, イギリス, オランダ, イタリア, イスラエル, 大韓民国