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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: Completed Phase 2 study, sponsored by EMD Serono.
NCT01693068 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 194 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment (otherwise censored), whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum sinc
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 |
What the finished NCT01693068 record still lists
NCT01693068 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 2 interventions - of which Dacarbazine is the first listed.
NCT01693068 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01693068's enrollment target sits among peer trials
194 352nd of 2000 higher than 1,649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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