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NCT04245397 · ClinicalTrials.gov registry record · Phase 1
Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
A Phase 1 study of Myelodysplastic Syndromes, sponsored by Syntrix Biosystems.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 151
- Enrollment target
- 7
- Study locations
NCT04245397: Recruiting Phase 1 study of Myelodysplastic Syndromes, sponsored by Syntrix Biosystems.
NCT04245397 is a Phase 1 study of Myelodysplastic Syndromes that is actively recruiting participants, run by Syntrix Biosystems. The registered enrollment target is 151 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (47% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04245397, a Phase 1 study of Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Syntrix Biosystems.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 151 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
Primary Outcome
Participants cohorts will be enrolled at increasing doses of SX-682. The highest SX-682 dose tested at which no more than 1 of 6 participants experiences a dose limiting toxicity will define the SX-682 MTD
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG SX-682
Study Locations (7)
Florida
- Mayo Clinic - Jacksonville
- University of Miami - Miami
- AdventHealth Medical Group & Bone Marrow Transplant at Orlando - Orlando
- Moffitt Cancer Center - Tampa
Georgia
- Emory University - Atlanta
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
What NCT04245397 shows while recruiting
NCT04245397 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Decitabine is the first listed.
NCT04245397 lists 7 locations in 4 states (Florida, Georgia, Maryland).
Frequently Asked Questions
What is clinical trial NCT04245397 about?
NCT04245397 is a clinical study titled "Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome". This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
What is the current status of trial NCT04245397?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2020-06-30. Estimated completion is 2029-03.
What conditions does trial NCT04245397 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes.
What interventions are being tested in trial NCT04245397?
The interventions under investigation include: Decitabine (DRUG), SX-682 (DRUG).
Who is sponsoring clinical trial NCT04245397?
This trial is sponsored by Syntrix Biosystems, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04245397 being conducted?
This trial has 7 study locations across Florida, Georgia, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndromes
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 NCT04245397's enrollment target sits among peer trials
151 41st of 173 higher than 133 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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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