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NCT02392793 · ClinicalTrials.gov registry record · Phase 1
Talazoparib Plus Irinotecan With or Without Temozolomide in Children With Refractory or Recurrent Solid Malignancies
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02392793 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 43 participants.
The verdict
NCT02392793, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The drug, talazoparib, seems to work against cancer in test tubes and animals by preventing DNA repair in damaged cells leading to their death. Investigators do not know if talazoparib combined with irinotecan will work in humans. Talazoparib has been used in only a small number of adults and children, and there is much not yet known about it. In Arm A of this study, investigators seek to find the safest dose of irinotecan to give with talazoparib to children and young adults. In a phase I study, different dose levels of drug may be tested. The first 2 or 3 patients will be given a dose, and if none of them has a bad side-effect, the next 2 or 3 patients will be given a higher dose. No temozolomide will be given in in Arm A. The experimental drug combination of talazoparib and irinotecan will be tested in the hopes of finding a treatment that may be effective against recurrent or refractory solid tumors. The goals of study Arm A are: * To determine whether the combination of talazoparib and irinotecan is a beneficial treatment for your cancer; * To learn what kind of side effects talazoparib can cause; * To learn what kind of side effects talazoparib in combination with irinotecan can cause; * To learn more about the biology of talazoparib in children diagnosed with solid tumors. The purpose of Arm B is to to find the safest doses of irinotecan and temozolomide to give with talazoparib to children and young adults with a solid malignancy.. Talazoparib belongs to a family of drugs called "poly ADP ribose polymerase or PARP inhibitors." Irinotecan and temozolomide belong to a family of drugs called "DNA damaging agents." There are two arms of this trial, A and B. In this study, investigators hope that irinotecan (administered in Arm A) and irinotecan plus temozolomide (administered in Arm B) will damage the DNA of the cancer cells. Then, talazoparib (which is a PARP inhibitor) will block the repair of the cancer cell's damaged DNA, causing the cancer cell to die
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG Talazoparib
- DRUG Filgrastim
- DRUG Peg-filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-03-25 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02392793
The ClinicalTrials.gov registry entry for NCT02392793 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT02392793 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02392793 about?
NCT02392793 is a clinical study titled "Talazoparib Plus Irinotecan With or Without Temozolomide in Children With Refractory or Recurrent Solid Malignancies". The drug, talazoparib, seems to work against cancer in test tubes and animals by preventing DNA repair in damaged cells leading to their death. Investigators do not know if talazoparib combined with irinotecan will work in humans. Talazoparib has been used in only a small number of adults and childr...
What is the current status of trial NCT02392793?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2015-03-25. Estimated completion is 2019-08-30.
What interventions are being tested in trial NCT02392793?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), Talazoparib (DRUG), Filgrastim (DRUG), Peg-filgrastim (DRUG).
Who is sponsoring clinical trial NCT02392793?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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