A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-39
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ramucirumab
DrugAdministered IV
Cyclophosphamide
DrugAdministered orally
Vinorelbine
DrugAdministered IV
Gemcitabine
DrugAdministered IV
Docetaxel
DrugAdministered IV
Abemaciclib
DrugAdministered orally
Irinotecan
DrugAdministered IV
Temozolomide
DrugAdministered orally
Treatment groups
105 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)Experimental treatment 3 interventions
Group B: Cyclophosphamide + Vinorelbine (DSRCT ISA)Active comparator 2 interventions
Group C: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)Experimental treatment 3 interventions
Group D: Gemcitabine + Docetaxel (SS ISA)Active comparator 2 interventions
Group E: Abemaciclib + Irinotecan + Temozolomide (ES ISA)Experimental treatment 3 interventions
Group F: Irinotecan + Temozolomide (ES ISA)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants Allocated to Each ISA
Number of Participants Allocated to Each ISA
Time frame
Baseline up to Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov