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NCT01122901 · ClinicalTrials.gov registry record · Phase 2
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Recurrent or Progressive Glioblastoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT01122901: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01122901 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01122901, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with recurrent or progressive glioblastoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Time to event endpoints for Group A will be measured from the date of first dose. All patients who receive at least one dose of study drug will be included in the analysis. Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment). Progression defined as: \>25% increase sum of products of perpendicular diameters (bi-dimensional measurements) of enhancing lesions (over baseline (BL) if no decrease) on stable or increas
Interventions
- OTHER laboratory biomarker analysis
- PROCEDURE therapeutic conventional surgery
- OTHER pharmacological study
- DRUG gamma-secretase/Notch signalling pathway inhibitor RO4929097
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
Why NCT01122901 stopped before completion
NCT01122901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01122901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01122901 about?
NCT01122901 is a clinical study titled "Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Recurrent or Progressive Glioblastoma". This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with recurrent or progressive glioblastoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes...
What is the current status of trial NCT01122901?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2010-12. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01122901?
The interventions under investigation include: laboratory biomarker analysis (OTHER), therapeutic conventional surgery (PROCEDURE), pharmacological study (OTHER), gamma-secretase/Notch signalling pathway inhibitor RO4929097 (DRUG).
Who is sponsoring clinical trial NCT01122901?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01122901's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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