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NCT04901702 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Recurrent Malignant Solid Neoplasm and Recurrent Osteosarcoma, sponsored by St. Jude Children's Research Hospital.

Recruiting
Registry status
Phase 1
Development phase
90
Enrollment target
10
Study locations

NCT04901702 is a Phase 1 study of Recurrent Malignant Solid Neoplasm and Recurrent Osteosarcoma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 90 participants, below the 298-participant average among 37 other Recurrent Malignant Solid Neoplasm trials with a reported enrollment target (70% lower). The trial reports 10 study locations across 9 states.

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The verdict

NCT04901702, a Phase 1 study of Recurrent Malignant Solid Neoplasm and Recurrent Osteosarcoma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.

RECRUITING
Registry status
Phase 1
Development phase
90 participants
Enrollment target
10
Study locations

Study Summary

The phase I portion of this study is designed for children or adolescents and young adults (AYA) with a diagnosis of a solid tumor that has recurred (come back after treatment) or is refractory (never completely went away). The trial will test 2 combinations of therapy and participants will be randomly assigned to either Arm A or Arm B. The purpose of the phase I study is to determine the highest tolerable doses of the combinations of treatment given in each Arm. In Arm A, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and talazoparib. Onivyde works by damaging the DNA of the cancer cell and talazoparib works by blocking the repair of the DNA once the cancer cell is damaged. By damaging the tumor DNA and blocking the repair, the cancer cells may die. In Arm B, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and temozolomide. Both of these medications work by damaging the DNA of the cancer call which may cause the tumor(s) to die. Once the highest doses are reached in Arm A and Arm B, then "expansion Arms" will open. An expansion arm treats more children and AYAs with recurrent or refractory solid tumors at the highest doses achieved in the phase I study. The goal of the expansion arms is to see if the tumors go away in children and AYAs with recurrent or refractory solid tumors. There will be 3 "expansion Arms". In Arm A1, children and AYAs with recurrent or refractory solid tumors (excluding Ewing sarcoma) will receive Onivyde and talazoparib. In Arm A2, children and AYAs with recurrent or refractory solid tumors, whose tumors have a problem with repairing DNA (identified by their doctor), will receive Onivyde and talazoparib. In Arm B1, children and AYAs with recurrent or refractory solid tumors (excluding Ewing sarcoma) will receive Onivyde and temozolomide. Once the highest doses of medications used in Arm A and Arm B are determined, then a phase II st

Conditions Studied

Recurrent Malignant Solid Neoplasm Recurrent Osteosarcoma Recurrent Ewing Sarcoma Recurrent Hepatoblastoma Recurrent Neuroblastoma Recurrent Malignant Germ Cell Tumor Recurrent Solid Tumor Recurrent Rhabdomyosarcoma Recurrent Peripheral Primitive Neuroectodermal Tumor Recurrent Rhabdoid Tumor

Interventions

  • DRUG Temozolomide
  • DRUG Talazoparib
  • DRUG Onivyde

Study Locations (10)

Other

  • CHU Sainte-Justine - Montreal
  • BC Children's Hospital Research Institute - Vancouver

California

  • Lucille Packard Children's Hospital Stanford - Palo Alto

Colorado

  • Children's Hospital Colorado - Aurora

District of Columbia

  • Children's National Medical Center - Washington D.C.

Georgia

  • Children's Healthcare of Atlanta/Emory University School of Medicine - Atlanta

Minnesota

  • Children's Hospital and Clinics of Minn - Minneapolis

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Texas

  • Texas Children's Hospital/ Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2021-06-09
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

St. Jude Children's Research Hospital

410 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04901702

The ClinicalTrials.gov registry entry for NCT04901702 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 298-participant average among 37 other Recurrent Malignant Solid Neoplasm trials with a reported enrollment target (70% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Recurrent Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.

NCT04901702 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT04901702 about?

NCT04901702 is a clinical study titled "Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma". The phase I portion of this study is designed for children or adolescents and young adults (AYA) with a diagnosis of a solid tumor that has recurred (come back after treatment) or is refractory (never completely went away). The trial will test 2 combinations of therapy and participants will be rando...

What is the current status of trial NCT04901702?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2021-06-09. Estimated completion is 2026-12-31.

What conditions does trial NCT04901702 study?

This clinical trial studies the following conditions: Recurrent Malignant Solid Neoplasm, Recurrent Osteosarcoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Neuroblastoma.

What interventions are being tested in trial NCT04901702?

The interventions under investigation include: Temozolomide (DRUG), Talazoparib (DRUG), Onivyde (DRUG).

Who is sponsoring clinical trial NCT04901702?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04901702 being conducted?

This trial has 10 study locations across California, Colorado, District of Columbia, Georgia, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.