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Набира участници Фаза 2 NCT05999994

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Neoplasms Child Adolescent

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.
Кой може да участва
Inclusion Criteria: Participants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll. * Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). * The participant has a Lansky (\<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50. * Participants must have discontinued all previous treatments for cancer or investigational agents greater than or equal to (≥)7 days after the last dose and must have recovered from clinically significant side effects. * The participant has adequate hematologic and organ function. * Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose. * Both female and male participants of childbearing potential must agree to use highly effective contraceptive precautions during the trial and for at least 3 months following the last dose of study drug. Participants will be ineligible if they meet any of the exclusion criteria below. Additional criteria are specified in the protocol amendment to which the participant will enroll. * Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol. * Participants who have active infections requiring therapy. * Participants who have had allogeneic bone marrow or solid organ transplant. * Participants who have had, or are planning to have, certain invasive procedures. * Female participants who are pregnant or breastfeeding.
Места на провеждане 10
Австралия (1)
Chris O'Brien Lifehouse
Camperdown
Белгия (1)
UCL- Saint Luc
Brussels
Франция (1)
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux
Германия (1)
Universitaetsklinikum Essen
Essen
Италия (1)
IRCCS Istituto Ortopedico Rizzoli
Bologna
Япония (1)
National Cancer Center Hospital
Chūōku
Нидерландия (1)
Leids Universitair Medisch Centrum
Leiden
Испания (1)
Hospital de la Santa Creu i Sant Pau
Barcelona
Великобритания (1)
University College Hospital - London
London
САЩ (1)
Childrens Hospital of Alabama
Birmingham , Alabama
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
1 Year
Максимална възраст
39 Years
Здрави доброволци
Не
Начална дата
22.01.2020
Крайна дата
01.05.2027
Регистрационен номер
NCT05999994
Източник
anzctr
Запитване за медицински туризъм

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