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Recruiting Phase 2 NCT05999994

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

Phase 2 – studying effectiveness and dosage
Conditions: Neoplasms Child Adolescent

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 10
Australia (1)
Chris O'Brien Lifehouse
Camperdown
Belgium (1)
UCL- Saint Luc
Brussels
France (1)
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux
Germany (1)
Universitaetsklinikum Essen
Essen
Italy (1)
IRCCS Istituto Ortopedico Rizzoli
Bologna
Japan (1)
National Cancer Center Hospital
Chūōku
Netherlands (1)
Leids Universitair Medisch Centrum
Leiden
Spain (1)
Hospital de la Santa Creu i Sant Pau
Barcelona
United Kingdom (1)
University College Hospital - London
London
United States (1)
Childrens Hospital of Alabama
Birmingham , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
39 Years
Healthy volunteers
No
Start date
22.01.2020
Completion date
01.05.2027
Registry ID
NCT05999994
Source
anzctr
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