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NCT03323034 · ClinicalTrials.gov registry record · Phase 1
Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma
A Phase 1 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03323034: Completed Phase 1 study, sponsored by Children's Oncology Group.
NCT03323034 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03323034, a Phase 1 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of pevonedistat when given together with irinotecan hydrochloride and temozolomide in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma that have come back after a period of improvement (recurrent) or that do not respond to treatment (refractory). Pevonedistat and irinotecan may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pevonedistat, irinotecan hydrochloride, and temozolomide may work better in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma compared to irinotecan and temozolomide alone.
Primary Outcome
The maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) will be the maximum dose at which fewer than one-third of patients experience dose limiting toxicities.
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG Pevonedistat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-01-11 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 1 |
What the finished NCT03323034 record still lists
NCT03323034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT03323034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03323034 about?
NCT03323034 is a clinical study titled "Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma". This phase I trial studies the side effects and best dose of pevonedistat when given together with irinotecan hydrochloride and temozolomide in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma that have come back after a period of improvement (recurrent) or that ...
What is the current status of trial NCT03323034?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-01-11. Estimated completion is 2024-09-30.
What interventions are being tested in trial NCT03323034?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), Pevonedistat (DRUG).
Who is sponsoring clinical trial NCT03323034?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03323034's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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
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