A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
- Conditions
- AdolescentNeoplasmsChild
- Interventions
- Registration Number
- NCT05999994
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 105
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA) Vinorelbine Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA). Ramucirumab + Gemcitabine + Docetaxel (SS ISA) Ramucirumab Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA. Cyclophosphamide + Vinorelbine (DSRCT ISA) Cyclophosphamide Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA. Abemaciclib + Irinotecan + Temozolomide (ES ISA) Irinotecan Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA. Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA) Cyclophosphamide Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA). Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA) Ramucirumab Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA). Cyclophosphamide + Vinorelbine (DSRCT ISA) Vinorelbine Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA. Gemcitabine + Docetaxel (SS ISA) Docetaxel Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA. Ramucirumab + Gemcitabine + Docetaxel (SS ISA) Gemcitabine Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA. Ramucirumab + Gemcitabine + Docetaxel (SS ISA) Docetaxel Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA. Gemcitabine + Docetaxel (SS ISA) Gemcitabine Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA. Abemaciclib + Irinotecan + Temozolomide (ES ISA) Abemaciclib Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA. Abemaciclib + Irinotecan + Temozolomide (ES ISA) Temozolomide Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA. Irinotecan + Temozolomide (ES ISA) Irinotecan Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA. Irinotecan + Temozolomide (ES ISA) Temozolomide Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
- Primary Outcome Measures
Name Time Method Number of Participants Allocated to Each ISA Baseline up to Week 4 Number of Participants Allocated to Each ISA
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (66)
Childrens Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Childrens Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Children's Hospital of Colorado
🇺🇸Denver, Colorado, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Golisano Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Children's Healthcare of Atlanta, Inc. at Egleston
🇺🇸Atlanta, Georgia, United States
Scroll for more (56 remaining)Childrens Hospital of Alabama🇺🇸Birmingham, Alabama, United StatesGregory FriedmanPrincipal Investigator