Trial · NCT05879367
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
NCT05879367, Phase 1, Recruiting, Orbus Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma. Trials, record NCT05879367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05879367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
- NCT number
- NCT05879367
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 66 participants, estimated
- Lead sponsor
- Orbus Therapeutics, Inc.
- Conditions
- Glioblastoma, IDH-wildtype, Glioblastoma, Glioblastoma Multiforme, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, GBM, Astrocytoma, Astrocytoma, IDH-Mutant
- Interventions
- Eflornithine (Dose Level 1), Eflornithine (Dose Level 2), Eflornithine (Dose Level -1), Temozolomide
- First posted
- 2023-05-30
- Last updated
- 2025-06-25
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of Dose Limiting Toxicities | 8 weeks | Protocol Defined Dose Limiting Toxicities |
| Primary | Incidence of TEAEs All Grades | From enrollment to the follow-up visit 4 weeks after end of treatment | All Grades |
| Primary | Incidence of TEAEs Grade 3+ | From enrollment to the follow-up visit 4 weeks after end of treatment | Grade 3+ |
| Primary | Incidence of TEAEs Serious | From enrollment to the follow-up visit 4 weeks after end of treatment | Serious |
| Primary | Incidence of TEAEs Leading to Discontinuation | From enrollment to the end of treatment | Leading to Discontinuation |
| Primary | Vital Signs (Heart and Respiratory Rate) | From enrollment to the follow-up visit 4 weeks after end of treatment | Change from Baseline in Heart Rate and Respiratory Rate |
| Primary | Vital Signs (Blood Pressure) | From enrollment to the follow-up visit 4 weeks after end of treatment | Change from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure |
| Primary | Incidence of Treatment-Emergent Abnormalities in Clinical Laboratory Tests | From enrollment to the follow-up visit 4 weeks after end of treatment | Lab abnormalities by CTCAE v5.0 Grade |
| Secondary | Overall Survival | From enrollment to up to 2 years after last dose | Until death or initiation of new anticancer therapy |
| Secondary | Progression Free Survival | From enrollment to the follow-up visit 4 weeks after end of treatment | Per RANO Criteria as assessed by MRI |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05879367
GET https://conductscience.org/api/trials/v1/NCT05879367/registered