Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo
2020年10月9日 更新者：Eli Lilly and Company
Randomized, Double-Blind, Placebo Controlled, Phase 2 Study of Pemetrexed and Cisplatin Plus Enzastaurin Versus Pemetrexed and Cisplatin Plus Placebo in Chemonaive Patients With Advanced, Unresectable, or Metastatic (Stage IIIB or IV) Nonsquamous Non-Small Cell Lung Cancer
This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts:
- Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy
- Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin + enzastaurin versus pemetrexed + cisplatin + placebo. Participants to be included in Part 2 are those with Nonsquamous Non-Small Cell Lung Cancer (NSCLC).
調査の概要
研究の種類
介入
入学 (実際)
35
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Bergamo、イタリア、24128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Catania、イタリア、95100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Padova、イタリア、35128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Trento、イタリア、38100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gauting、ドイツ、82131
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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GroBhansdorf、ドイツ、D-22927
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hamburg、ドイツ、D 21075
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Heidelberg、ドイツ、69126
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Leuven、ベルギー、3000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Otwock、ポーランド、05-400
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poznan、ポーランド、60-569
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bucharest、ルーマニア、022328
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- diagnosis of advanced NSCLC not amenable to curative treatment. Participants enrolling in Part 2 of the study must have the above stated diagnosis of NSCLC that is also of nonsquamous histology.
- no prior systemic therapies [chemotherapy, et cetera (etc.)] or pleurodesis with chemotherapy for this disease
- prior radiotherapy is allowed but must be completed at least 2 weeks before study enrollment and participant must be recovered from the acute toxic effects
- have a good performance status
- participant must sign an informed consent document
Exclusion Criteria:
- participant had myocardial infarction occurring less than 6 months before inclusion, uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not controlled by medications
- participant is unable to swallow tablets
- participant is taking a certain medicine to control seizure activity, called "enzyme inducing antiepileptic drugs" and is not able to stop taking the medicine prior to enrolling in the study
- participant is unable to interrupt aspirin and/or other anti-inflammatory agents
- participant is unwilling or unable to take vitamin supplementation (folic acid and vitamin B12) or medications to prevent side effects
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
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：Enzastaurin + Pemetrexed + Cisplatin
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1125 milligrams (mg) loading dose then 500 mg, oral (po), daily (QD), until disease progression
他の名前：
500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle
他の名前：
75 mg/m², IV, every 21 days, for each 21-day cycle
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プラセボコンパレーター：Placebo + Pemetrexed + Cisplatin
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500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle
他の名前：
75 mg/m², IV, every 21 days, for each 21-day cycle
po, QD
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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 |
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Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation]
時間枠：Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up
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Presented are data that evaluates safety based on toxicity using Common Terminology Criteria for Adverse Events (CTCAE v3.0), SAEs, and discontinuations due to SAEs or other non-serious adverse events (AE's) of study participants.
A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module.
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Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up
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Part 2: Compare Progression-Free Survival (PFS) Between the 2 Treatment Arms Through the Assessment of Tumor Response
時間枠：Baseline to measured PD up to 5 months
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PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause.
For participants not known to have died as of the data cut-off date and who did not have objective progressive disease (PD), PFS was censored at the date of the last objective progression-free assessment.
For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS was censored at the date of last objective progression-free assessment prior to the initiation of post discontinuation anticancer therapy.
PFS was calculated and analyzed based on an alternative definition of censoring; for each participant who is not known to have died or who have had objective disease progression as of the data cut-off date, PFS was censored at the date of last prior contact.
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline to measured PD up to 5 months
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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 |
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Part 2: To Evaluate the Safety and Toxicity Profile of Study Treatments
時間枠：Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up
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The safety and toxicity profile for Part 2 was defined as serious adverse events (SAEs) and other non-serious adverse events (AEs).
A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module.
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Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up
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Part 2: Number of Participants With a Complete Response (CR) or Partial Response (PR) (Response Rate)
時間枠：Baseline to measured progressive disease (PD) up to 5 months
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Response rate was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria.
Complete Response (CR) was defined as the disappearance of all target lesions.
Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions.
Best response was confirmed by a second assessment in ≥28 days.
Response rate was defined as the number of participants with best response of CR or PR divided by the total number of treated participants.
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline to measured progressive disease (PD) up to 5 months
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Part 2: Overall Survival (OS)
時間枠：Baseline to date of death from any cause up to 5 months
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OS time was defined as the time from the date of study enrollment to the date of death from any cause.
For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post discontinuation was equal to the last known alive date in mortality status).
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline to date of death from any cause up to 5 months
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Part 2: Duration of Disease Control (DDC) and Response
時間枠：Baseline to measured PD up to 5 months
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DDC and response defined as time from complete response (CR), partial response (PR) or stable disease (SD) to first date of objectively determined progressive disease (PD) or death from any cause using RECIST (v1.0) criteria.
CR defined as disappearance of all target lesions.
PR defined as having ≥30% decrease in sum of longest diameter (LD) of target lesions.
PD defined as having ≥20% increase in the sum of the LD of target lesions.
SD defined as small changes not meeting above criteria.
Participants not known to have died as of data cut-off date, had no objective PD or were lost to follow-up, DCC was censored at date of last objective progression-free assessment (OPFA).
Participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objective PD or death were censored at date of last OPFA prior to initiation of post discontinuation anticancer therapy.
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline to measured PD up to 5 months
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Part 2: Time to Worsening of Symptoms (TWS)
時間枠：Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up
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TWS was measured from the date of study enrollment to the first date of a worsening in any of the 6 Lung Cancer Symptom Scale (LCSS) symptoms (appetite, cough, fatigue, shortness of breath, hemoptysis and pain).
Participants marked each symptom on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (as good as it can be/none) to 100 mm (as bad/much as it could be).
TWS was also measured individually for each of the 6 symptoms independently and were also measured from the date of enrollment to the first date of worsening in pain.
For both measurements, worsening was defined as a 15-mm increase from baseline in the participant-reported score for any symptom.
Participants who are not known to have had a worsening TWS were censored at the date of the participant's last LCSS assessment.
Zero participants were analyzed in this outcome as study was terminated early.
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Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up
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Part 2: To Assess Biomarkers of the Disease State and Their Correlation to Clinical Outcome
時間枠：Baseline, Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and end of study up to 5 months
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Presented are data that evaluates of biomarkers relevant to the study drug and the disease state of the participant's clinical outcome.
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline, Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and end of study up to 5 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UCT/GMT - 5 hours, EST)、Eli Lilly and Company
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年9月1日
一次修了 (実際)
2008年11月1日
研究の完了 (実際)
2008年11月1日
試験登録日
最初に提出
2007年10月1日
QC基準を満たした最初の提出物
2007年10月1日
最初の投稿 (見積もり)
2007年10月3日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月5日
QC基準を満たした最後の更新が送信されました
2020年10月9日
最終確認日
2020年10月1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。