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NCT01905228 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
A Phase 1 study of Glioblastoma and Solid Tumors, sponsored by Incuron.
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
- 4
- Study locations
NCT01905228: Completed Phase 1 study of Glioblastoma and Solid Tumors, sponsored by Incuron.
NCT01905228 is a Phase 1 study of Glioblastoma and Solid Tumors that has completed, run by Incuron. The registered enrollment target is 83 participants, below the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (23% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01905228, a Phase 1 study of Glioblastoma and Solid Tumors, has completed, sponsored by Incuron.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is an open-label, multi-center, sequential groups, dose-escalation study of CBL0137 administered intravenously in participants with metastatic or unresectable advanced solid malignancies.
Primary Outcome
MTD is defined as dose level at which ≥6 participants have been treated and which is associated with a first-cycle DLT in ≤17% of the participants. Selection of RP2D from within the tolerated dose range will be based on evaluation of short- and long-term safety information together with findings relating to compliance, pharmacokinetics, pharmacodynamics and antitumor activity.
Conditions Studied
Interventions
- DRUG CBL0137
Study Locations (4)
Ohio
- University Hospital of Cleveland - Cleveland
- Cleveland Clinic - Cleveland
New York
- Roswell Park Cancer Institute - Buffalo
Texas
- CTRC at The University of Texas Healh Science Center at San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2013-07 |
| Est. Completion | 2019-06 |
| Phase | Phase 1 |
What the finished NCT01905228 record still lists
NCT01905228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (23% lower).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which CBL0137 is the first listed.
NCT01905228 reports a single indexed study location in Ohio, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT01905228 about?
NCT01905228 is a clinical study titled "A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm". This is an open-label, multi-center, sequential groups, dose-escalation study of CBL0137 administered intravenously in participants with metastatic or unresectable advanced solid malignancies.
What is the current status of trial NCT01905228?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2013-07. Estimated completion is 2019-06.
What conditions does trial NCT01905228 study?
This clinical trial studies the following conditions: Glioblastoma, Solid Tumors.
What interventions are being tested in trial NCT01905228?
The interventions under investigation include: CBL0137 (DRUG).
Who is sponsoring clinical trial NCT01905228?
This trial is sponsored by Incuron, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01905228 being conducted?
This trial has 4 study locations across New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01905228's enrollment target sits among peer trials
83 55th of 199 higher than 144 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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