Recruiting

Phase 2

LY900023A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

Sponsor:

Eli Lilly and Company

Code:

NCT05999994

Conditions

Neoplasms

Child

Adolescent

Eligibility Criteria

Sex: All

Age: 1 - 39

Healthy Volunteers: Not accepted

Interventions

Ramucirumab

Cyclophosphamide

Vinorelbine

Gemcitabine

Docetaxel

Study Details

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.

Conditions

Neoplasms

Child

Adolescent

Study ID

NCT05999994

Start date

Jan 22, 2020

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 1 - 39

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)

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).

active comparator: Cyclophosphamide + Vinorelbine (DSRCT ISA)

Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.

experimental: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)

Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.

active comparator: Gemcitabine + Docetaxel (SS ISA)

Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.

experimental: Abemaciclib + Irinotecan + Temozolomide (ES ISA)

Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.

active comparator: Irinotecan + Temozolomide (ES ISA)

Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.

Interventions

Ramucirumab

Administered IV

Cyclophosphamide

Administered orally

Vinorelbine

Administered IV

Gemcitabine

Administered IV

Docetaxel

Administered IV

Abemaciclib

Administered orally

Irinotecan

Administered IV

Temozolomide

Administered orally

Primary outcome measure

Number of Participants Allocated to Each ISA [ Time Frame: Baseline up to Week 4 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

602-546-0990

Principal Investigator:

Alok Kothari

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Principal Investigator:

Alok Kothari

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Principal Investigator:

Josephine HaDuong

Children's Hospital of Colorado

Recruiting

Denver, Colorado, United States, 80218

Contacts

720-777-6740

Principal Investigator:

Margaret Macy

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

202-476-4744

Principal Investigator:

AeRang Kim

Golisano Children's Hospital of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

239-343-5437

Principal Investigator:

Emad Salman

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

904-953-2000

Principal Investigator:

Steven Attia

Ann & Robert H Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

312-227-4834

Principal Investigator:

David Walterhouse

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

816-302-6808

Principal Investigator:

Kevin Ginn

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

212-639-8856

Principal Investigator:

Emily Slotkin

Nationwide Children's Hosp

Recruiting

Columbus, Ohio, United States, 43205-2664

Contacts

614-355-1202

Principal Investigator:

Mark Ranalli

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Principal Investigator:

Andrew Bukowinski

Lifespan Cancer Institute

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

401-829-6552

Principal Investigator:

Bradley DeNardo

University of Texas Southwestern Medical Center at Dallas

Recruiting

Dallas, Texas, United States, 75390-9063

Principal Investigator:

Theodore Laetsch

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

713-745-6754

Principal Investigator:

Najat Daw

Seattle Children's Hospital Research Foundation

Recruiting

Seattle, Washington, United States, 98105

Contacts

206-987-2114

Principal Investigator:

Catherine Albert

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-07.