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NCT01742988 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
A Phase 1 study, sponsored by Curis.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
NCT01742988: Completed Phase 1 study, sponsored by Curis.
NCT01742988 is a Phase 1 study that has completed, run by Curis. The registered enrollment target is 106 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01742988, a Phase 1 study, has completed, sponsored by Curis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
Study Summary
This is a phase 1, open-label, dose-escalation study of fimepinostat (CUDC-907) in patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL), or high-grade B-cell lymphoma (HGBL) with or without MYC and BCL2 alterations. Fimepinostat (CUDC-907) is a multi-targeted agent designed to inhibit phosphoinositide 3-kinase (PI3K)and histone deacetylase (HDAC). The study is designed to assess the safety, the maximum tolerated dose, the recommended phase 2 dose (RP2D), pharmacokinetics and the anti-cancer activity of oral fimepinostat in combination with 1 or more anti-cancer regimens.
Primary Outcome
To be evaluated in patients with relapsed and/or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Within any given study arm, the highest dose level studied at which fewer than 2 out of 6 subjects (\< 33%) experience a dose limiting toxicity (DLT).
Interventions
- DRUG Rituximab
- DRUG venetoclax
- DRUG fimepinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2012-12 |
| Est. Completion | 2020-10-09 |
| Phase | Phase 1 |
What the finished NCT01742988 record still lists
NCT01742988 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT01742988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01742988 about?
NCT01742988 is a clinical study titled "Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma". This is a phase 1, open-label, dose-escalation study of fimepinostat (CUDC-907) in patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL), or high-grade B-cell lymphoma (HGBL) with or without MYC and BCL2 alterations. Fimepinostat (CUDC-907) is a multi-targeted agent designed...
What is the current status of trial NCT01742988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2012-12. Estimated completion is 2020-10-09.
What interventions are being tested in trial NCT01742988?
The interventions under investigation include: Rituximab (DRUG), venetoclax (DRUG), fimepinostat (DRUG).
Who is sponsoring clinical trial NCT01742988?
This trial is sponsored by Curis, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01742988's enrollment target sits among peer trials
106 531st of 2000 higher than 1,468 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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