Informations générales (source: ClinicalTrials.gov)
CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research (CAMPFIRE)
Interventional
Phase 2
Eli Lilly and Company (Voir sur ClinicalTrials)
janvier 2020
mai 2027
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69008 - Lyon - Rhône-Alpes - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest - 33076 - Bordeaux - Aquitaine - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.