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Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC

2016年7月28日 更新者：Boehringer Ingelheim

A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer

The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy.

The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

143

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

  • カナダ
    • Alberta
      • Edmonton、Alberta、カナダ
        • 1230.5.00104 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Kelowna、British Columbia、カナダ
        • 1230.5.00114 Boehringer Ingelheim Investigational Site
      • Surrey、British Columbia、カナダ
        • 1230.5.00109 Boehringer Ingelheim Investigational Site
      • Vancouver、British Columbia、カナダ
        • 1230.5.00107 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton、Ontario、カナダ
        • 1230.5.00105 Boehringer Ingelheim Investigational Site
      • Kitchener、Ontario、カナダ
        • 1230.5.00119 Boehringer Ingelheim Investigational Site
      • Oshawa、Ontario、カナダ
        • 1230.5.00116 Boehringer Ingelheim Investigational Site
      • Ottawa、Ontario、カナダ
        • 1230.5.00108 Boehringer Ingelheim Investigational Site
      • Toronto、Ontario、カナダ
        • 1230.5.00110 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal、Quebec、カナダ
        • 1230.5.00102 Boehringer Ingelheim Investigational Site
      • Montreal、Quebec、カナダ
        • 1230.5.00106 Boehringer Ingelheim Investigational Site
  • バハマ
      • Nassau、バハマ
        • 1230.5.00118 Boehringer Ingelheim Investigational Site

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:

  1. Pathologic or cytologic confirmed diagnosis of NSCLC
  2. Recurrent, advanced or metastatic NSCLC that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)
  3. Patients who are eligible for pemetrexed as second line chemotherapy
  4. Measurable disease by one or more techniques (CT, MRI) according to RECIST
  5. Patients aged 18 years or older
  6. Life expectancy of at least three (3) months
  7. Eastern Cooperative Oncology Group (ECOG) performance Score 0-2
  8. Written informed consent that is consistent with ICH-GCP guidelines and local legislation

Exclusion criteria:

  1. Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
  2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of Cycle 1 of this trial
  3. Any persisting toxicities which are deemed to be clinically significant from the previous therapy
  4. Patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors.
  5. Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
  6. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded.
  7. Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
  8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
  9. Patients unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily
  10. Patients who have received prior therapy with pemetrexed
  11. Absolute neutrophil count (ANC) less than 1,500/mm3
  12. Platelet count less than 100,000/mm3
  13. Hemoglobin <90g/L
  14. Total bilirubin >26µmol/L
  15. Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) less than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable
  16. Serum creatinine level >133µmol/L and/or creatinine clearance (measured or calculated) <45 ml/min
  17. Clinically relevant QTc prolongation
  18. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  19. Pregnancy or breast feeding
  20. Known or suspected active alcohol or drug abuse
  21. Patients unable to comply with the protocol
  22. Any known hypersensitivity to the trial drugs or their excipients
  23. Patients with NSCLC of confirmed Squamous histology

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：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
実験的：BI 6727 +pemetrexed
BI 6727 plus 500 mg/^m2 pemetrexed i.v. on day 1 of 21 day cycle
薬：pemetrexed
500 mg/m^2 i.v. on day 1 of 21 day cycle
薬：BI 6727
BI 6727 i.v. on day 1 of a 21 day cycle
アクティブコンパレータ：pemetrexed
500 mg/m^2 i.v. on day 1 of a 21 day cycle
薬：pemetrexed
500 mg/m^2 i.v. on day 1 of 21 day cycle

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
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.
時間枠：From randomization until disease progression or death

Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.

The number of participants analysed displays the number of patients with an event (progression).
From randomization until disease progression or death

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.
時間枠：From first drug infusion until 21 days after last drug infusion, up to 1100 days
Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Overall Survival (OS)
時間枠：From randomization until time of death
Overall survival (OS) was defined as the duration of time from randomization to time of death.
From randomization until time of death
Duration of Overall Response
時間枠：From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.
From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
Occurrence and Intensity of AEs Graded According to CTCAE.
時間枠：From first drug infusion until 21 days after last drug infusion, up to 1100 days
All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE).
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Occurence of DLT
時間枠：Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.

Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:

  • treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).
  • treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.
  • CTCAE Grade 4 thrombocytopenia.
Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.
Frequency of Patients With Possible Clinically Significant Abnormalities
時間枠：From first drug infusion until 21 days after last drug infusion, up to 1100 days
Frequency of patients with possible clinically significant abnormalities
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Cmax of Volasertib
時間枠：5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Cmax - maximum measured concentration of volasertib in plasma.
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Total Clearance (CL) of Volasertib
時間枠：5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
CL - total clearance of volasertib in plasma after IV administration
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Vss of Volasertib
時間枠：5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Vss - apparent volume of distribution at steady state following IV administration of volasertib
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Cmax of Pemetrexed
時間枠：5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Cmax - maximum measured concentration of pemetrexed in plasma
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
CL of Pemetrexed
時間枠：5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
CL - total clearance of pemetrexed in plasma after IV administration
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Vss of Pemetrexed
時間枠：5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Vss - apparent volume of distribution at steady state following IV administration of pemetrexed
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion

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

Boehringer Ingelheim

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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

2009年3月1日

一次修了 (実際)

2012年9月1日

研究の完了 (実際)

2015年8月1日

試験登録日

最初に提出

2009年1月15日

QC基準を満たした最初の提出物

2009年1月15日

最初の投稿 (見積もり)

2009年1月16日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年9月20日

QC基準を満たした最後の更新が送信されました

2016年7月28日

最終確認日

2016年7月1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

  • 1230.5

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。

がん、非小細胞肺の臨床試験

  • Adelphi Values LLC
    Blueprint Medicines Corporation
    完了
    全身性肥満細胞症の患者報告アウトカムアンケート
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    アメリカ

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