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NCT01116687 · ClinicalTrials.gov registry record · Phase 2
RO4929097 in Treating Patients With Metastatic Colorectal Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT01116687: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01116687 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116687, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
This phase II trial studies how well RO4929097 works in treating patients with metastatic colorectal cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
To determine the objective radiographic response rate associated with RO4929097 in patients with metastatic colorectal cancer who have progressed following at least 2 prior treatments in the metastatic setting. Radiologic assessment of tumor burden (CT scans of the chest, abdomen and pelvis, or MRI of the abdomen and pelvis and CT of the chest) was scheduled every 8 weeks. Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) were used for evaluation of the primary endpoint.
Interventions
- OTHER laboratory biomarker analysis
- DRUG gamma-secretase/Notch signalling pathway inhibitor RO4929097
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT01116687 record still lists
NCT01116687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT01116687 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116687 about?
NCT01116687 is a clinical study titled "RO4929097 in Treating Patients With Metastatic Colorectal Cancer". This phase II trial studies how well RO4929097 works in treating patients with metastatic colorectal cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT01116687?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2010-05. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01116687?
The interventions under investigation include: laboratory biomarker analysis (OTHER), gamma-secretase/Notch signalling pathway inhibitor RO4929097 (DRUG).
Who is sponsoring clinical trial NCT01116687?
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 NCT01116687's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 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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