- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00969761
BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
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Bruxelles, Бельгия
- 1230.6.3201 Boehringer Ingelheim Investigational Site
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Leuven, Бельгия
- 1230.6.3202 Boehringer Ingelheim Investigational Site
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion criteria:
- 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
- Indication for a treatment with platinum therapy as judged by the investigator
- Age 18 years or older
- Written informed consent consistent with ICH-GCP and local legislation
- ECOG performance score lower or equal 2
- Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)
Exclusion criteria:
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
- Pregnancy or breastfeeding
- Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II
- Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
- Second malignancy currently requiring another anti-cancer therapy
- ANC less than 1500 / mm3
- Platelet count less than 100 000 / mm3
- Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome)
- 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)
- 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)
- Known history of relevant QT-prolongation, e.g. long QT-syndrome
- Pre-existing clinically relevant hearing loss
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
- 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
- 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.
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: A. BI 6727-cisplatin
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin
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low to high dose
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Экспериментальный: B. BI 6727-carboplatin
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin
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Low to high dose (administered every 3 weeks).
Depending on the toxicities observed, intermediary dose levels may be added
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Maximum Tolerated Dose
Временное ограничение: 3 weeks
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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
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Percentage of Participants With Dose Limiting Toxicities
Временное ограничение: 3 weeks
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Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle.
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3 weeks
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Objective Response Rate
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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
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Duration of Objective Response
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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
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Best Overall Response
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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.
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From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Disease Control Rate
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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.
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From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Duration of Disease Control
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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.
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From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Progression-free Survival
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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.
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From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Incidence and Intensity of Adverse Events According to CTCAE Version 3.0
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0
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From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Percentage of Participants With Serious Adverse Events
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Percentage of participants with serious adverse events (AEs)
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From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Percentage of Participants With Significant Adverse Events
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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:
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From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Total Plasma Clearance After Intravascular Administration (CL)
Временное ограничение: 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
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Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
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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
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Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)
Временное ограничение: 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
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Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
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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
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Change From Baseline in Pulse Rate
Временное ограничение: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Change from baseline in pulse rate at last value on treatment
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Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Change From Baseline in Neutrophils
Временное ограничение: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Change from baseline in neutrophils with the maximum value on treatment
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Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Change From Baseline in Platelets
Временное ограничение: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Change from baseline in platelets with the maximum value on treatment
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Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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).
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From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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
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Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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
Временное ограничение: 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
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Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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
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Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment
Временное ограничение: 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
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Worst CTCAE Grade on Treatment for Platelets
Временное ограничение: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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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
Временное ограничение: 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).
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From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 1230.6
- 2008-003926-40 (Номер EudraCT: EudraCT)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования BI 6727
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Boehringer IngelheimЗавершенныйНовообразованияСоединенные Штаты, Тайвань
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Boehringer IngelheimЗавершенныйНовообразованияВенгрия
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Northwestern UniversityNational Cancer Institute (NCI); National Comprehensive Cancer NetworkОтозванРецидивирующий острый лимфобластный лейкоз у взрослых | Рефрактерный острый лимфобластный лейкоз у взрослыхСоединенные Штаты
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Boehringer IngelheimЗавершенныйНовообразованияТайвань
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Boehringer IngelheimЗавершенныйНовообразованияБельгия
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Boehringer IngelheimПрекращеноЗдоровыйСоединенное Королевство
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Boehringer IngelheimРекрутингИсследование на людях с запущенным раком для проверки того, как BI 907828 обрабатывается в организмеСолидные опухолиВенгрия
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Boehringer IngelheimЗавершенный
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Boehringer IngelheimЗавершенный
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Boehringer IngelheimЕще не набирают