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NCT01078961 · ClinicalTrials.gov registry record · Phase 1
An Expanded Cohort Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01078961: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01078961 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01078961, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This research study involves the use of two investigational drugs: sorafenib and bortezomib. Sorafenib is designed to stop the growth of cells caused by changes associated with cancer. Bortezomib is designed to stop cancer cells from getting rid of waste products. This causes the cells to build up toxic levels of waste that leads to cell death. In the laboratory, the combination of sorafenib and bortezomib has been shown to fight cancer cells better than either drug alone. We are looking to determine if the combination of sorafenib and bortezomib is a safe treatment for patients with advanced melanoma. The effectiveness of this combination will also be assessed.
Primary Outcome
To determine the maximally tolerated dose of weekly bortezomib in combination with 400mg twice daily sorafenib.
Interventions
- DRUG sorafenib
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-09 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT01078961 record still lists
NCT01078961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which sorafenib is the first listed.
NCT01078961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01078961 about?
NCT01078961 is a clinical study titled "An Expanded Cohort Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma". This research study involves the use of two investigational drugs: sorafenib and bortezomib. Sorafenib is designed to stop the growth of cells caused by changes associated with cancer. Bortezomib is designed to stop cancer cells from getting rid of waste products. This causes the cells to build up t...
What is the current status of trial NCT01078961?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2010-09. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01078961?
The interventions under investigation include: sorafenib (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT01078961?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01078961's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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