Trial · NCT01269411
RO4929097 in Treating Patients With Recurrent Invasive Gliomas
NCT01269411, Phase 1, Terminated, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RO4929097 in Treating Patients With Recurrent Invasive Gliomas. Trials, record NCT01269411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01269411
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RO4929097 in Treating Patients With Recurrent Invasive Gliomas
- NCT number
- NCT01269411
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Recurrent Adult Brain Tumor
- Interventions
- gamma-secretase/Notch signalling pathway inhibitor RO4929097, therapeutic conventional surgery, pharmacological study, laboratory biomarker analysis
- First posted
- 2011-01-04
- Last updated
- 2013-02-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum-tolerated dose (MTD) defined as the dose level in which less than or equal to 1 out of 6 patients experience dose limiting toxicity (DLT) assessed using NCI CTCAE version 4.0 | 21 days | |
| Primary | Pharmacokinetic (PK) profile of RO4909297 | Pre-dose, 1, 2, 4, 8, and 24 hours | |
| Secondary | Progression-free survival following treatment with R04929097 | From registration to time of progression or death, whichever occurs first, assessed up to 12 months | The Kaplan-Meier method will be used. |
| Secondary | Inhibition of p75NTR cleavage and processing | Up to 12 months | Descriptive statistics, such as the mean, median and range, will be used to summarize the marker across patients. The Wilcoxon signed-rank and rank sum tests will be used. |
| Secondary | Establishment and growth of BTIC cultures in neurosphere growth conditions, effects on proliferation, ability to self-renewal, and ability to differentiate along lineage-specific pathways | Up to 12 months | Descriptive statistics, such as the mean, median and range, will be used to summarize the marker across patients. The Wilcoxon signed-rank and rank sum tests will be used. |
| Secondary | Inhibition of Notch signaling, by assessing downstream target activation | Up to 12 months | Descriptive statistics, such as the mean, median and range, will be used to summarize the marker across patients. The Wilcoxon signed-rank and rank sum tests will be used. |
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.
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/NCT01269411
GET https://conductscience.org/api/trials/v1/NCT01269411/registered