Trial · NCT02502708
Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
NCT02502708, Phase 1, Completed, NewLink Genetics Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors. Trials, record NCT02502708. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02502708
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
- NCT number
- NCT02502708
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 81 participants, actual
- Lead sponsor
- NewLink Genetics Corporation
- Conditions
- Glioblastoma Multiforme, Glioma, Gliosarcoma, Malignant Brain Tumor, Ependymoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma, Primary CNS Tumor
- Interventions
- Indoximod, Temozolomide, Conformal Radiation, Cyclophosphamide, Etoposide
- First posted
- 2015-07-20
- Last updated
- 2020-06-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of regimen limiting toxicities (RLTs) | First 28 days of treatment | To estimate the RP2D of indoximod combined with temozolomide |
| Primary | Objective Response Rate | Up to three years | To assess preliminary evidence of efficacy of indoximod and temozolomide using COG brain tumor measurement criteria. |
| Primary | Incidence of regimen limiting toxicities (RLTs) | First 35 days of treatment | To estimate the RP2D of indoximod combined with conformal radiation |
| Primary | Safety and tolerability assessed by development of AEs and laboratory parameters of indoximod in combination with cyclophosphamide and etoposide. | Up to three years | In patients who initially achieve prolonged stable disease or better with Indoximod plus temozolomide but then develop progressive disease |
| Secondary | Pharmacokinetics: Serum concentrations (Cmax/Steady State) | First 48 hours of treatment | Group 1 |
| Secondary | Safety and Tolerability of Indoximod combined with Temozolomide as assessed by incidence and severity of adverse events, dose interruptions and dose reductions. | Continuous during study until 30 days after study treatment is complete. | Group 1 and 2 |
| Secondary | Progression Free Survival (PFS) | Up to three years | Group 2 |
| Secondary | Time to Progression | Start of study until disease progression follow-up, up to three years | Group 2 |
| Secondary | Overall Survival | Start of study until end of follow-up, up to five years | Group 2 |
| Secondary | Safety and Feasibility of Indoximod combined with conformal radiation as assessed by incidence and severity of adverse events, dose interruptions and dose reductions. | Continuous during study until 30 days after study treatment is complete. | Group 3 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37715730 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02502708
GET https://conductscience.org/api/trials/v1/NCT02502708/registered