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NCT01517464 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Systemic Gene Therapy With SGT-94 in Patients With Solid Tumors
A Phase 1 study of Neoplasm, sponsored by SynerGene Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01517464: Completed Phase 1 study of Neoplasm, sponsored by SynerGene Therapeutics.
NCT01517464 is a Phase 1 study of Neoplasm that has completed, run by SynerGene Therapeutics. The registered enrollment target is 13 participants, below the 201-participant average among 11 other Neoplasm trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01517464, a Phase 1 study of Neoplasm, has completed, sponsored by SynerGene Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I study designed to evaluate the safety and maximum tolerated dose (MTD) of SGT-94, a novel, tumor-targeted, systemic gene therapy agent for cancer. In addition, we will look for evidence of RB94 expression within tumor tissue after systemic administration of SGT-94.
Primary Outcome
The severity of adverse experiences in each patient will be determined based upon changes in the results of clinical laboratory tests and physical examnations. These findings will be used to determine the safety and tolerability of increasing doses of SGT-94.
Conditions Studied
Interventions
- GENETIC SGT-94
Study Locations (1)
Texas
- University of Texas, M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01517464 record still lists
NCT01517464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 201-participant average among 11 other Neoplasm trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which SGT-94 is the first listed.
NCT01517464 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01517464 about?
NCT01517464 is a clinical study titled "A Phase I Study of Systemic Gene Therapy With SGT-94 in Patients With Solid Tumors". This is a Phase I study designed to evaluate the safety and maximum tolerated dose (MTD) of SGT-94, a novel, tumor-targeted, systemic gene therapy agent for cancer. In addition, we will look for evidence of RB94 expression within tumor tissue after systemic administration of SGT-94.
What is the current status of trial NCT01517464?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2012-01. Estimated completion is 2015-12.
What conditions does trial NCT01517464 study?
This clinical trial studies the following conditions: Neoplasm.
What interventions are being tested in trial NCT01517464?
The interventions under investigation include: SGT-94 (GENETIC).
Who is sponsoring clinical trial NCT01517464?
This trial is sponsored by SynerGene Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01517464 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasm
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 NCT01517464's enrollment target sits among peer trials
13 11th of 11 higher than 1 of 11 other Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasm 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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