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NCT02975882 · ClinicalTrials.gov registry record · Phase 1
Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
A Phase 1 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT02975882: Completed Phase 1 study, sponsored by Children's Oncology Group.
NCT02975882 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02975882, a Phase 1 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come back after treatment and a period of time during which the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nanoparticle albumin-bound rapamycin, temozolomide, and irinotecan hydrochloride may cause the cancer to stop growing or shrink for a period of time and may lessen the symptoms that are caused by the cancer.
Primary Outcome
Number of patients with cycle 1 and 2 dose limiting toxicities possibly, probably, or definitely attributable with nanoparticle albumin-bound rapamycin stratified by dose level.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Temozolomide
- DRUG Irinotecan Hydrochloride
- OTHER Pharmacological Study
- DRUG Sirolimus Albumin-bound Nanoparticles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-08-15 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 1 |
What the finished NCT02975882 record still lists
NCT02975882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02975882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02975882 about?
NCT02975882 is a clinical study titled "Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors". This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come back after treatment and a period of time during which the tumor could ...
What is the current status of trial NCT02975882?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2017-08-15. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT02975882?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Irinotecan Hydrochloride (DRUG), Pharmacological Study (OTHER), Sirolimus Albumin-bound Nanoparticles (DRUG).
Who is sponsoring clinical trial NCT02975882?
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 NCT02975882's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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