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NCT01693068 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma
A Phase 2 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
NCT01693068 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 194 participants.
The verdict
NCT01693068, a Phase 2 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
Study Summary
This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their relationship with pimasertib exposure.
Interventions
- DRUG Dacarbazine
- DRUG Pimasertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2012-12-05 |
| Est. Completion | 2016-10-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01693068
The ClinicalTrials.gov registry entry for NCT01693068 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dacarbazine is the first listed.
NCT01693068 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01693068 about?
NCT01693068 is a clinical study titled "Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma". This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free surv...
What is the current status of trial NCT01693068?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2012-12-05. Estimated completion is 2016-10-24.
What interventions are being tested in trial NCT01693068?
The interventions under investigation include: Dacarbazine (DRUG), Pimasertib (DRUG).
Who is sponsoring clinical trial NCT01693068?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
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