Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01781026 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Neoadjuvant Vemurafenib in Melanoma Patients With Untreated Brain Metastases
A Phase 2 study of Melanoma, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT01781026: Completed Phase 2 study of Melanoma, sponsored by Yale University.
NCT01781026 is a Phase 2 study of Melanoma that has completed, run by Yale University. The registered enrollment target is 2 participants, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01781026, a Phase 2 study of Melanoma, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this trial is to study the activity of vemurafenib in untreated melanoma brain metastases harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that are not amenable to stereotactic radiosurgery based on size, number of lesions or location, to measure cerebrospinal fluid (CSF) levels of vemurafenib as an indicator of central nervous system penetrance and to measure levels of vemurafenib in normal brain tissue and brain metastases in those in whom surgical management is feasible.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Conditions Studied
Interventions
- DRUG Vemurafenib
Study Locations (1)
Connecticut
- Smilow Cancer Hospital at Yale New Haven - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT01781026 record still lists
NCT01781026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Vemurafenib is the first listed.
NCT01781026 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01781026 about?
NCT01781026 is a clinical study titled "Phase 2 Study of Neoadjuvant Vemurafenib in Melanoma Patients With Untreated Brain Metastases". The purpose of this trial is to study the activity of vemurafenib in untreated melanoma brain metastases harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that are not amenable to stereotactic radiosurgery based on size, number of lesions or location, to measure cerebrospinal ...
What is the current status of trial NCT01781026?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2013-04. Estimated completion is 2014-06.
What conditions does trial NCT01781026 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT01781026?
The interventions under investigation include: Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01781026?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01781026 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
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 NCT01781026's enrollment target sits among peer trials
2 266th of 266 the lowest 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
RECRUITING · Phase 2
-
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
RECRUITING · Phase 2
-
Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma
RECRUITING · Phase 2
-
A Study of IBI363 in Subjects with Advanced Solid Malignancies
RECRUITING · Phase 2
-
A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
RECRUITING · Phase 2
-
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia