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NCT01462773 · ClinicalTrials.gov registry record · Phase 1
Study of Patients With Stage IV Malignant Melanoma Using PS-341 (Bortezomib, Velcade) and Interferon-alpha-2b in Malignant Melanoma
A Phase 1 study of Melanoma, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01462773: Completed Phase 1 study of Melanoma, sponsored by Ohio State University Comprehensive Cancer Center.
NCT01462773 is a Phase 1 study of Melanoma that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 16 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01462773, a Phase 1 study of Melanoma, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the safety, tolerability and dose limiting toxicities (DLTs) of VELCADE when administered in combination with interferon-alpha-2b (IFN-α-2b) to patients with metastatic malignant melanoma.
Primary Outcome
A standard method for the design of this study. Initially, three patients will be treated at a starting dose of VELCADE (1.0 mg/m2). If one of the three patients demonstrates a DLT, then an additional 3 patients will be treated at that dose level. If only one of the six show DLT, then the next cohort of three patients will be entered at the next dose level (1.3 mg/m2). If two or more of the six demonstrate DLT, no further patients will be treated at that dose level. The highest dose level at whi
Conditions Studied
Interventions
- DRUG Bortezomib
- DRUG Interferon Alfa-2b
Study Locations (1)
Ohio
- Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2006-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01462773 record still lists
NCT01462773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Bortezomib is the first listed.
NCT01462773 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01462773 about?
NCT01462773 is a clinical study titled "Study of Patients With Stage IV Malignant Melanoma Using PS-341 (Bortezomib, Velcade) and Interferon-alpha-2b in Malignant Melanoma". The purpose of this study is to determine the safety, tolerability and dose limiting toxicities (DLTs) of VELCADE when administered in combination with interferon-alpha-2b (IFN-α-2b) to patients with metastatic malignant melanoma.
What is the current status of trial NCT01462773?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2006-01. Estimated completion is 2013-04.
What conditions does trial NCT01462773 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT01462773?
The interventions under investigation include: Bortezomib (DRUG), Interferon Alfa-2b (DRUG).
Who is sponsoring clinical trial NCT01462773?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01462773 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01462773's enrollment target sits among peer trials
16 238th of 266 higher than 27 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
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