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NCT02267083 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of GPX-150 to Treat Soft Tissue Sarcoma
A Phase 2 study of Soft Tissue Sarcoma, sponsored by Gem Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 4
- Study locations
NCT02267083: Completed Phase 2 study of Soft Tissue Sarcoma, sponsored by Gem Pharmaceuticals.
NCT02267083 is a Phase 2 study of Soft Tissue Sarcoma that has completed, run by Gem Pharmaceuticals. The registered enrollment target is 22 participants, below the 79-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (72% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02267083, a Phase 2 study of Soft Tissue Sarcoma, has completed, sponsored by Gem Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will assess the safety and efficacy of GPX-150 administered intravenously every 3 weeks in the treatment of patients with soft tissue sarcoma.
Primary Outcome
The primary efficacy endpoint is the number of patients who were progression-free at 12 months, which is obtained by inversion of the Kaplan-Meier curve for progression-free survival (PFS) at 12 months. Of note, the statistical comparison to historical sarcoma data described in the protocol was not performed due to an enrollment of less than the planned sample size of 30 subjects. Progression is defined using RECIST 1.1, as at least a 20% increase in the sum of diameters of target lesions, takin
Conditions Studied
Interventions
- DRUG GPX-150 for Injection
Study Locations (4)
Illinois
- Northwestern University - Chicago
Iowa
- University of Iowa Holden Comprehensive Cancer Center - Iowa City
Missouri
- Washington University School of Medicine - St Louis
Pennsylvania
- Penn State Milton S Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-01-07 |
| Est. Completion | 2016-08-18 |
| Phase | Phase 2 |
What the finished NCT02267083 record still lists
NCT02267083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 79-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which GPX-150 for Injection is the first listed.
NCT02267083 reports a single indexed study location in Illinois, Iowa, Missouri.
Frequently Asked Questions
What is clinical trial NCT02267083 about?
NCT02267083 is a clinical study titled "Efficacy and Safety Study of GPX-150 to Treat Soft Tissue Sarcoma". This study will assess the safety and efficacy of GPX-150 administered intravenously every 3 weeks in the treatment of patients with soft tissue sarcoma.
What is the current status of trial NCT02267083?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2015-01-07. Estimated completion is 2016-08-18.
What conditions does trial NCT02267083 study?
This clinical trial studies the following conditions: Soft Tissue Sarcoma.
What interventions are being tested in trial NCT02267083?
The interventions under investigation include: GPX-150 for Injection (DRUG).
Who is sponsoring clinical trial NCT02267083?
This trial is sponsored by Gem Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02267083 being conducted?
This trial has 4 study locations across Illinois, Iowa, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02267083's enrollment target sits among peer trials
22 46th of 55 higher than 10 of 55 other Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Soft Tissue Sarcoma 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.
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