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NCT01902381 · ClinicalTrials.gov registry record · Phase 2
CPI-613 in Treating Patients With Myelodysplastic Syndromes Who Failed Previous Therapy
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01902381: Clinical Trial Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT01902381 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01902381, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This pilot clinical trial studies 6, 8-bis (benzylthio) octanoic acid (CPI-613) in treating patients with myelodysplastic syndromes who failed previous therapy. Sometimes when chemotherapy or biological therapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to treatment. 6, 8-bis (benzylthio) octanoic acid may interfere with the growth of tumor cells and may be an effective treatment for myelodysplastic syndromes that did not respond to previous therapy.
Primary Outcome
Response rate (RR), defined as the combined of complete remission (CR), marrow CR, partial remission (PR), or stable disease (SD), as described by Cheson, et al. (2006). The number of patients achieving RR will be presented. Complete remission - Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines; Marrow CR - Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment Partial remission - All CR criteria if abnormal before treatment except: Bone marrow blasts decreas
Interventions
- DRUG 6,8-bis(benzylthio)octanoic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-11-26 |
| Phase | Phase 2 |
Why NCT01902381 stopped before completion
NCT01902381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which 6,8-bis(benzylthio)octanoic acid is the first listed.
NCT01902381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01902381 about?
NCT01902381 is a clinical study titled "CPI-613 in Treating Patients With Myelodysplastic Syndromes Who Failed Previous Therapy". This pilot clinical trial studies 6, 8-bis (benzylthio) octanoic acid (CPI-613) in treating patients with myelodysplastic syndromes who failed previous therapy. Sometimes when chemotherapy or biological therapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant t...
What is the current status of trial NCT01902381?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-08. Estimated completion is 2018-11-26.
What interventions are being tested in trial NCT01902381?
The interventions under investigation include: 6,8-bis(benzylthio)octanoic acid (DRUG).
Who is sponsoring clinical trial NCT01902381?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01902381's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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