Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT02392793 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
This study is a traditional dose escalation study using a standard 3+3 phase I design to define the MTD. Six or more dose levels will be evaluated for the combination of talazoparib and irinotecan. Each cycle will last 21 days with talazoparib given daily on days 1-6 and irinotecan given daily on days 2-6.
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 |
What the finished NCT02392793 record still lists
NCT02392793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT02392793 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02392793's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03726359 · 43 participants · Phase 1
Phase I Study of Fractionated Stereotactic Radiation Therapy
- NCT03850418 · 43 participants · Phase 2
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
- NCT04144023 · 43 participants · Phase 1
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
- NCT04176718 · 43 participants · Phase 2
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI