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NCT01280565 · ClinicalTrials.gov registry record · Phase 3
Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit
A Phase 3 study, sponsored by AB Science.
- Terminated
- Registry status
- Phase 3
- Development phase
- 134
- Enrollment target
NCT01280565: Clinical Trial Phase 3 study, sponsored by AB Science.
NCT01280565 is a Phase 3 study that was terminated before completion, run by AB Science. The registered enrollment target is 134 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01280565, a Phase 3 study, was terminated before completion, sponsored by AB Science.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 134 participants
- Enrollment target
Study Summary
The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit and who have not previously been treated for melanoma.
Primary Outcome
Estimated as the number of patients with documented partial response or complete response defined according to the RECIST criteria, divided by the number of randomized patients
Interventions
- DRUG Dacarbazine
- DRUG Masitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2011-01 |
| Est. Completion | 2019-08 |
| Phase | Phase 3 |
Why NCT01280565 stopped before completion
NCT01280565 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Dacarbazine is the first listed.
NCT01280565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01280565 about?
NCT01280565 is a clinical study titled "Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit". The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit and who have not previously been treated for melanoma.
What is the current status of trial NCT01280565?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2011-01. Estimated completion is 2019-08.
What interventions are being tested in trial NCT01280565?
The interventions under investigation include: Dacarbazine (DRUG), Masitinib (DRUG).
Who is sponsoring clinical trial NCT01280565?
This trial is sponsored by AB Science, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01280565's enrollment target sits among peer trials
134 1585th of 2000 higher than 413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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