GSK1120212 Food-effect Study
An Open-Label, Two-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Single Dose Pharmacokinetics of the MEK Inhibitor, GSK1120212, in Subjects With Solid Tumors
調査の概要
詳細な説明
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
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Michigan
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Detroit、Michigan、アメリカ、48201
- GSK Investigational Site
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- GSK Investigational Site
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Texas
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San Antonio、Texas、アメリカ、78229
- GSK Investigational Site
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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:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female; 18 years of age or older at the time of consent
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Able to swallow and retain oral medication.
- Histologically or cytologically confirmed diagnosis of a solid tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 3).
Adequate baseline organ function defined in Table 5 Definitions for Adequate Baseline Organ Function Absolute neutrophil count greater than or equal to 1.2 × 109/L Hemoglobin greater than or equal to9 g/dL Platelets greater than or equal to 75 × 109/L Prothrombin time (PT), International normalization ratio (INR)a and Partial thromboplastin time (PTT) less than or equal to 1.5 times ULN Hepatic Total bilirubin less than or equal to 1.5 times ULN ALT less than or equal to 2.5 times ULN Renal Creatinine or less than or equal to 1.5 times ULN Calculated creatinine clearance or greater than or equal to 50 mL/min 24-hour urine creatinine clearance greater than or equal to 50 mL/min Cardiac LVEF greater than or equal to LLNc by ECHO or MUGA
- INR greater than 1.5 times ULN will be acceptable in case of subjects receiving therapeutic anticoagulants such as warfarin as long as INR is monitored during the study according to clinical practice.
- Calculated by the Cockcroft-Gault formula (see Appendix 2).
- If LLN is not defined for a given institution, then ejection fraction must be greater than or equal to 50%.
- Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception, as defined in Section 7.1.1, during the study and for 6 weeks following the last dose of study treatment.
- Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in Section 7.1.2 from the time of the first dose of study treatment until 16 weeks following the last dose of study treatment (based on the lifecycle of sperm).
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Currently receiving cancer therapy (e.g., chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or major surgery) within 3 weeks prior to randomization; chemotherapy regimens without delayed toxicity within 2 weeks prior to randomization; or use of an investigational anti-cancer drug within 4 weeks prior to randomization.
- Has unresolved Grade 2 or greater toxicity (based on NCI-CTCAE, version 4.0) [NCI Common Terminology Criteria for Adverse Events, 2009] from previous anti-cancer therapy except Grade 2 decreased hemoglobin levels or alopecia.
- Has pre-existing peripheral neuropathy of greater than or equal to Grade 2.
- Has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer, prior to the first dose of study treatment in this study.
- Has participated in a study that resulted in or made a donation of blood or blood products in excess of 500 mL within 56 days of the first dose of study treatment.
- Has presence of active GI disease or other condition (e.g., gastrectomy, bariatric surgery, small or large bowel resection, or cholecystectomy should be excluded) that may interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, contact the GSK Medical Monitor.
- Has any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.
- Has a history of interstitial lung disease or pneumonitis.
Is currently using a prohibited medication(s) or requires the use of any of the prohibited medications during the study (see Section 8.2).
• NOTE: Use of anticoagulants such as warfarin is permitted; however, INR must be monitored in accordance with local institutional practice.
Has a history or current evidence/risk of RVO or CSR:
- History of RVO or CSR, or predisposing factors to RVO or CSR (i.e., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension or diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
- Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
- Evidence of new optic disc cupping
- Intraocular pressure greater than 21 mmHg as measured by tonography
Has symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
- Note: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for greater than 3 months, are asymptomatic and are not currently taking corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to Day 1 of the study are permitted.
- Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs (EIAEDs).
- Has a QtcB or QTcF (preferred) greater than or equal to 480 msec.
- Has a history or evidence of cardiovascular risk including any of the following:
- History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for greater 30 days prior to randomization are eligible.
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
- History or evidence of current greater than or equal to Class II congestive heart failure as defined by New York Heart Association (NYHA) (Appendix 4).
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:ランダム化
- 介入モデル:クロスオーバー割り当て
- 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:Treatment A
GSK1120212 Dose /Treatment 2.0 mg/Fasted
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Oral/once-daily single doses on Day 1 of Periods 1 and 2
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実験的:Treatment B
GSK1120212 Dose /Treatment 2.0 mg/high fat, high calorie meal
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Oral/once-daily single doses on Day 1 of Periods 1 and 2
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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 |
---|---|---|
evaluate the effect of a high-fat, high-calorie meal on the PK of a single dose of GSK1120212 administered to subjects
時間枠:Predose - 168 hours post dose period 1 and 2
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• Area under the plasma concentration-time curve from time zero (pre-dose) to time t (AUC(0-t)), AUC(0-inf), Cmax, and tmax.
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Predose - 168 hours post dose period 1 and 2
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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 |
---|---|---|
assess the short-term safety and tolerability of single oral doses of 2.0 mg of GSK1120212 administered to subjects
時間枠:Day 1/periods 1 and 2, Day 8 period 2 and follow-up.
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vital signs, electrocardiograms (ECGs), clinical laboratory tests, and AEs
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Day 1/periods 1 and 2, Day 8 period 2 and follow-up.
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協力者と研究者
スポンサー
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 113709
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。
癌の臨床試験
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
GSK1120212の臨床試験
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National Cancer Institute (NCI)積極的、募集していない
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National Cancer Institute (NCI)Children's Oncology Group積極的、募集していない
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Jonsson Comprehensive Cancer CenterNovartis; Stand Up To Cancer; Prostate Cancer Foundation積極的、募集していない
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National Cancer Institute (NCI)完了
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National Cancer Institute (NCI)完了
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National Cancer Institute (NCI)NRG Oncology完了子宮内膜明細胞腺癌 | 子宮内膜混合細胞腺癌 | 子宮内膜漿液性腺癌 | 子宮内膜未分化がん | 子宮内膜腺癌 | 再発子宮体がんアメリカ
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National Cancer Institute (NCI)完了
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National Cancer Institute (NCI)GlaxoSmithKline完了IV期乳がん | 再発乳癌 | 浸潤性乳癌 | エストロゲン受容体陰性 | HER2/Neu陰性 | プロゲステロン受容体陰性 | トリプルネガティブ乳がんアメリカ
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Saint Petersburg State University, Russia引きこもった