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BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour

2018年8月21日 更新者：Boehringer Ingelheim

A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumors

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin).

Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.

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)

61

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

  • ベルギー
      • Bruxelles、ベルギー
        • 1230.6.3201 Boehringer Ingelheim Investigational Site
      • Leuven、ベルギー
        • 1230.6.3202 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. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
  2. Indication for a treatment with platinum therapy as judged by the investigator
  3. Age 18 years or older
  4. Written informed consent consistent with ICH-GCP and local legislation
  5. ECOG performance score lower or equal 2
  6. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)

Exclusion criteria:

  1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
  2. Pregnancy or breastfeeding
  3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II
  4. Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
  5. Second malignancy currently requiring another anti-cancer therapy
  6. ANC less than 1500 / mm3
  7. Platelet count less than 100 000 / mm3
  8. Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome)
  9. 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)
  10. Serum creatinine greater than 1.5 mg / dl (> 132 micromol / L, SI unit equivalent) or creatinine clearance <70ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate)
  11. Known history of relevant QT-prolongation, e.g. long QT-syndrome
  12. Pre-existing clinically relevant hearing loss
  13. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  14. Treatment with other investigational drugs or participation in another clinical interventional trial within the past four weeks before start of therapy or concomitantly with this trial
  15. Systemic anti-cancer therapy or radiotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
  16. Patients unable to comply with the protocol
  17. 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
  • 割り当て：非ランダム化
  • 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：A. BI 6727-cisplatin
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin
薬：BI 6727
low to high dose
実験的：B. BI 6727-carboplatin
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin
薬：BI-6727
Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added

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
Maximum Tolerated Dose
時間枠：3 weeks

The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin.

0=not maximum tolerated dose, 1=was maximum tolerated dose.
3 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With Dose Limiting Toxicities
時間枠：3 weeks
Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle.
3 weeks
Objective Response Rate
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Objective response was defined as the proportion of participants having at least a best response of complete response (CR) or partial response (PR) determined based on RECIST criteria, version 1.0 (V1.0).

Tumour response was documented using appropriate techniques
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Objective Response
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Duration of objective response was defined as the time from first documented confirmed complete response (CR) or partial response (PR) to first evidence of progressive disease (PD) or death from any cause, whichever occurred first, determined based on RECIST V1.0 criteria.

Tumour response was documented using appropriate techniques
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Best Overall Response
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Best overall response was defined as the best response obtained since the start of study treatment until disease progression, determined based on RECIST V1.0 criteria.
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Disease Control Rate
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of participants with confirmed disease control, defined as the proportion of patients with a best overall response of at least stable disease (SD), determined based on RECIST V1.0 criteria.
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Disease Control
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Disease control was defined as the time from the start of study treatment to the time of disease progression or death, whichever occurred first.
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Progression-free Survival
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Progression-free survival based on RECIST V1.0 criteria was defined as the time from start of treatment to the date of evidence of progressive disease (PD) or death from any cause, whichever occurred first.
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of Participants With Serious Adverse Events
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of participants with serious adverse events (AEs)
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of Participants With Significant Adverse Events
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with significant adverse events (AEs): dose limiting toxicity (DLT) was defined as significant AE.

DLTs (i.e. significant AEs) per protocol were:

  • drug related CTCAE grade 3 or 4 non haematological toxicity (except vomiting or diarrhoea responding to supportive treatment and ototoxicity)
  • drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection
  • drug related CTCAE Grade 4 thrombocytopenia
  • drug related febrile neutropenia grade 3 (ANC<1000/mm³ and fever≥ 38.5°C)
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Total Plasma Clearance After Intravascular Administration (CL)
時間枠：1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)
時間枠：1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Change From Baseline in Pulse Rate
時間枠：Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change from baseline in pulse rate at last value on treatment
Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change From Baseline in Neutrophils
時間枠：Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change from baseline in neutrophils with the maximum value on treatment
Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change From Baseline in Platelets
時間枠：Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change from baseline in platelets with the maximum value on treatment
Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of participants (%) with possible clinically significant abnormalities for neutrophils: : defined as neutrophils >=CTCAE grade 2 (CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Frequency of participants (%) with possible clinically significant abnormalities for platelets : defined as platelets >=CTCAE grade 2 (based on CTCAE v3.0), with worsening from baseline.

The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on last value on treatment.

Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on last value on treatment.

Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on worst value on treatment.

Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on worst value on treatment.

Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst CTCAE Grade on Treatment for Platelets
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst CTCAE Grade on Treatment for Neutrophils
時間枠：From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 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。

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8月1日

一次修了 (実際)

2011年11月1日

研究の完了 (実際)

2012年2月1日

試験登録日

最初に提出

2009年8月31日

QC基準を満たした最初の提出物

2009年8月31日

最初の投稿 (見積もり)

2009年9月1日

学習記録の更新

投稿された最後の更新 (実際)

2019年1月31日

QC基準を満たした最後の更新が送信されました

2018年8月21日

最終確認日

2018年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 1230.6
  • 2008-003926-40 (EudraCT番号：EudraCT)

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。

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