A Study of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations (MK-8669-021 AM1)
A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations
調査の概要
状態
条件
詳細な説明
Allocation and Arms Additional Information: All Patients will receive an 8-week
open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)
Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-study.
研究の種類
入学 (実際)
段階
- フェーズ2
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 histologically confirmed stage IIIB/IV non-small cell lung cancer
- Patient has a documented mutation of the KRAS gene
- Patient has evidence of disease progression following 1 but no more than 3 prior chemotherapy regimens
- A minimum of 4 weeks has passed since the most recent anti-cancer treatment
- Women of childbearing potential must have a negative pregnancy test prior to start of therapy and must use an approved contraceptive method for the duration of the study
- Patient has adequate organ function
- Patient has performance status of <=2 on Eastern Cooperative Oncology Group (ECOG) performance scale
- Patient is >=18 years of age
Exclusion Criteria:
- Patient has received more than 2 prior chemotherapy regimens for the treatment lung cancer
- Patient is known to have active brain metastases
- Patient is currently participating or has participated in an investigational drug study within 30 days
- Patient is known to be Human Immunodeficiency Virus (HIV) positive or has a known history of Hepatitis B or C
- Patient has an active infection requiring prescribed intervention
- Patient has newly diagnosed or un-controlled Type 1 or 2 diabetes
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:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
プラセボコンパレーター:プラセボ
|
Four 10mg tablets of ridaforolimus once daily for five consecutive days each week followed by 2 days days of treatment holiday, during the 8 week lead in treatment period.
他の名前:
Four tablets of blinded placebo (to match ridaforolimus) administered daily for 5 consecutive days each week followed by 2 days of treatment holiday
|
実験的:Ridaforolimus
|
Four 10mg tablets of ridaforolimus once daily for five consecutive days each week followed by 2 days days of treatment holiday, during the 8 week lead in treatment period.
他の名前:
Four tablets of blinded ridaforolimus administered daily for 5 consecutive days each week followed by 2 days days of treatment holiday
他の名前:
|
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 |
---|---|
Progression-free survival (PFS) in the randomized population
時間枠:Randomization (Week 8) and every 8 weeks until progressive disease or death
|
Randomization (Week 8) and every 8 weeks until progressive disease or death
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Overall response rate (ORR) in the full analysis population
時間枠:Study entry (Visit 1) and every 8 weeks until progressive disease or death
|
Study entry (Visit 1) and every 8 weeks until progressive disease or death
|
Overall survival (OS) in the full analysis population
時間枠:From study entry (Visit 1) to death due to any cause
|
From study entry (Visit 1) to death due to any cause
|
OS in the randomized population
時間枠:From study entry (Visit 1) to death due to any cause
|
From study entry (Visit 1) to death due to any cause
|
PFS in the full analysis population
時間枠:Study entry (Visit 1) and every 8 weeks until progressive disease or death
|
Study entry (Visit 1) and every 8 weeks until progressive disease or death
|
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
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 (見積もり)
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。
非小細胞肺がんの臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
Lead-In Ridaforolimusの臨床試験
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Boston UniversityOhio State University; Centers for Disease Control and Prevention; US Department of Housing and...募集
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BlueWillow BiologicsPorton Biopharma Ltd.完了
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HK inno.N Corporationまだ募集していません