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A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120

2014年11月24日 更新者：Boehringer Ingelheim

Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120

The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.

Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.

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)

41

段階

  • フェーズ 1

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

  • ドイツ
      • Freiburg/Breisgau、ドイツ
        • 1199.16.49001 Boehringer Ingelheim Investigational Site
      • Grosshansdorf、ドイツ
        • 1199.16.49004 Boehringer Ingelheim Investigational Site
      • Tübingen、ドイツ
        • 1199.16.49008 Boehringer Ingelheim Investigational Site
      • Wiesbaden、ドイツ
        • 1199.16.49005 Boehringer Ingelheim Investigational Site
  • フランス
      • Bordeaux cedex、フランス
        • 1199.16.3306A Boehringer Ingelheim Investigational Site
      • Clichy Cedex、フランス
        • 1199.16.3311A Boehringer Ingelheim Investigational Site
      • Clichy Cedex、フランス
        • 1199.16.3311B Boehringer Ingelheim Investigational Site
      • Paris、フランス
        • 1199.16.3312A Boehringer Ingelheim Investigational Site
      • Paris Cedex 10、フランス
        • 1199.16.3313A Boehringer Ingelheim Investigational Site
      • Paris Cedex 10、フランス
        • 1199.16.3313E Boehringer Ingelheim Investigational Site
      • Paris cedex 15、フランス
        • 1199.16.3302A 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. Male or female patients with advanced solid tumours who have completed a previous study with BIBF 1120. The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF 1120.
  2. Age 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2
  4. Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)

Exclusion Criteria:

  1. Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks
  2. Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120
  3. Active ulcers (gastro-intestinal tract, skin)
  4. Major injuries and surgery within the past three weeks with incomplete wound healing
  5. Hypersensitivity to BIBF 1120 or the excipients of the trial drug
  6. Known secondary malignancy requiring therapy
  7. Active infectious disease
  8. Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure > NYHA II)
  9. Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
  10. Brain metastases requiring therapy
  11. Absolute neutrophil count less than 1,500/mm3
  12. Platelet count less than 100,000/mm3
  13. Bilirubin greater than 1.5 mg/dl (> 26 µmol/L)
  14. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
  15. Serum creatinine greater than 2 mg/dl (> 176 µmol/L)
  16. Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
  17. Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug
  18. Patients who are sexually active and unwilling to use a medically acceptable method of contraception
  19. Pregnancy or lactation
  20. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial (except for a previous study with BIBF 1120)
  21. Patients unable to comply with the protocol
  22. Active alcohol or drug abuse

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

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
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
時間枠：From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2
時間枠：From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3
時間枠：From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4
時間枠：From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5
時間枠：From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Difference From Baseline for Liver Enzymes
時間枠：From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Bilirubin, Creatinine and Glucose
時間枠：From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Haemoglobin
時間枠：From baseline until end of treatment, up to 991 days
Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From baseline until end of treatment, up to 991 days
Difference From Baseline for Haematology and Differentials Parameters
時間枠：From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Coagulation Parameters
時間枠：From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Electrolytes
時間枠：From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Clinically Relevant Abnormalities for Vital Signs
時間枠：From baseline until final follow-up, up to 991 days
Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
From baseline until final follow-up, up to 991 days
Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)
時間枠：Just before drug administration every 28±7 days after day 29
Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29
Just before drug administration every 28±7 days after day 29
Unconfirmed Best Overall Response
時間枠：Baseline until end of treatment, up to 991 days

Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).

PD = Progressive disease.
Baseline until end of treatment, up to 991 days
Unconfirmed Best Objective Response
時間枠：Baseline until end of treatment, up to 991 days
Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Baseline until end of treatment, up to 991 days
Clinical Benefit
時間枠：Baseline until end of treatment, up to 991 days
Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).
Baseline until end of treatment, up to 991 days
Confirmed Objective Response
時間枠：Baseline until end of treatment, up to 991 days
Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Baseline until end of treatment, up to 991 days
Progression Free Survival
時間枠：First drug administration (in previous trial) until end of treatment, up to 1230 days

Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.

PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.

Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first.
First drug administration (in previous trial) until end of treatment, up to 1230 days

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。

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

2004年10月1日

一次修了 (実際)

2009年9月1日

試験登録日

最初に提出

2008年7月11日

QC基準を満たした最初の提出物

2008年7月14日

最初の投稿 (見積もり)

2008年7月15日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年12月2日

QC基準を満たした最後の更新が送信されました

2014年11月24日

最終確認日

2014年11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

  • 1199.16

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