Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

June 9, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Recurrent Solid TumorRecurrent Ewing SarcomaRecurrent HepatoblastomaRecurrent Malignant Germ Cell TumorRecurrent Malignant Solid NeoplasmRecurrent NeuroblastomaRecurrent OsteosarcomaRecurrent Peripheral Primitive Neuroectodermal TumorRecurrent Rhabdoid TumorRecurrent RhabdomyosarcomaRecurrent Soft Tissue SarcomaRecurrent Wilms TumorRefractory Ewing SarcomaRefractory HepatoblastomaRefractory Malignant Germ Cell TumorRefractory Malignant Solid NeoplasmRefractory NeuroblastomaRefractory OsteosarcomaRefractory Peripheral Primitive Neuroectodermal TumorRefractory Rhabdoid TumorRefractory RhabdomyosarcomaRefractory Soft Tissue Sarcoma
Interventions
DRUG

Onivyde

Given intravenous on Days 1 and 8

DRUG

Talazoparib

Given orally twice on Day 1 (daily maximum is 1000mcg/day), then daily on Days 2-6

DRUG

Temozolomide

Given once a day on Days 1-5.

Trial Locations (10)

20010

Children's National Medical Center, Washington D.C.

30322

Children's Healthcare of Atlanta/Emory University School of Medicine, Atlanta

38105

St. Jude Children's Research Hospital, Memphis

55404

Children's Hospital and Clinics of Minn, Minneapolis

77030

Texas Children's Hospital/ Baylor College of Medicine, Houston

80045

Children's Hospital Colorado, Aurora

94304

Lucille Packard Children's Hospital Stanford, Palo Alto

Unknown

The Hospital for Sick Children, Toronto

CHU Sainte-Justine, Montreal

BC Children's Hospital Research Institute, Vancouver

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Ipsen

INDUSTRY

lead

St. Jude Children's Research Hospital

OTHER