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NCT02502708 · ClinicalTrials.gov registry record · Phase 1
Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
A Phase 1 study, sponsored by NewLink Genetics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT02502708: Completed Phase 1 study, sponsored by NewLink Genetics Corporation.
NCT02502708 is a Phase 1 study that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02502708, a Phase 1 study, has completed, sponsored by NewLink Genetics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation significantly enhanced survival by driving a vigorous, tumordirected inflammatory response. This data provided the rationale for the companion adult phase 1 trial using indoximod (IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open (NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the clinic for children with brain tumors. This study will provide a foundation for future pediatric trials testing indoximod combined with radiation and temozolomide in the up-front setting for patients with newly diagnosed central nervous system tumors.
Primary Outcome
To estimate the RP2D of indoximod combined with temozolomide
Interventions
- DRUG Cyclophosphamide
- DRUG Temozolomide
- DRUG Etoposide
- DRUG Indoximod
- RADIATION Conformal Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2015-10 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 1 |
What the finished NCT02502708 record still lists
NCT02502708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02502708 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02502708 about?
NCT02502708 is a clinical study titled "Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors". This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma model, it was recently shown that adding IDO-...
What is the current status of trial NCT02502708?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2015-10. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT02502708?
The interventions under investigation include: Cyclophosphamide (DRUG), Temozolomide (DRUG), Etoposide (DRUG), Indoximod (DRUG), Conformal Radiation (RADIATION).
Who is sponsoring clinical trial NCT02502708?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02502708's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 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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