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NCT01014351 · ClinicalTrials.gov registry record · Phase 2
Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
A Phase 2 study of Metastatic Melanoma, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 12
- Study locations
NCT01014351: Completed Phase 2 study of Metastatic Melanoma, sponsored by SCRI Development Innovations.
NCT01014351 is a Phase 2 study of Metastatic Melanoma that has completed, run by SCRI Development Innovations. The registered enrollment target is 70 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (16% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01014351, a Phase 2 study of Metastatic Melanoma, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 12
- Study locations
Study Summary
Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate.
Primary Outcome
Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Everolimus
Study Locations (12)
Tennessee
- Chattanooga Oncology Hematology Associates - Chattanooga
- Tennessee Oncology, PLLC - Nashville
Florida
- Florida Cancer Specialists - Fort Myers
Georgia
- Northeast Georgia Medical Center - Gainesville
Indiana
- Oncology Hematology of SW Indiana - Evansville
Louisiana
- Hematology Oncology Clinic, LLP - Baton Rouge
Maryland
- Center for Cancer and Blood Disorders - Bethesda
Michigan
- Grand Rapids Oncology Program - Grand Rapids
Missouri
- Research Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2010-02 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01014351 record still lists
NCT01014351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT01014351 lists 12 locations in 11 states (Tennessee, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT01014351 about?
NCT01014351 is a clinical study titled "Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma". Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate.
What is the current status of trial NCT01014351?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2010-02. Estimated completion is 2013-08.
What conditions does trial NCT01014351 study?
This clinical trial studies the following conditions: Metastatic Melanoma.
What interventions are being tested in trial NCT01014351?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT01014351?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01014351 being conducted?
This trial has 12 study locations across Florida, Georgia, Indiana, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic 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 NCT01014351's enrollment target sits among peer trials
70 26th of 91 higher than 64 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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
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