Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 25, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Solid TumorsNeuroblastomaRhabdomyosarcomaEwing SarcomaHepatoblastomaMedulloblastoma
Interventions
DRUG

VAL-413

a flavored preparation of orally administered irinotecan

DRUG

Temozolomide

alkylating oral chemotherapy agent used to treatment brain cancers

Trial Locations (8)

20010

RECRUITING

Children's National Research Institute - Children's National Hospital, Washington D.C.

27514

RECRUITING

University of North Carolina at Chapel Hill - North Carolina Cancer Hospital, Chapel Hill

27710

RECRUITING

Duke University Children's Hospital and Health Center, Durham

28204

RECRUITING

Atrium Health Levine Children's Hospital - Carolinas Medical Center, Charlotte

37203

RECRUITING

Sarah Cannon Research Institute, Pediatric Hematology & Oncology, Nashville

46202

RECRUITING

Indiana University School of Medicine, Riley Hospital for Children, Indianapolis

94143

RECRUITING

UCSF, Mission Bay - Benioff Children's Hospital, San Francisco

45229-3039

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
lead

Valent Technologies, LLC

INDUSTRY