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NCT01134341 · ClinicalTrials.gov registry record · Phase 1
Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
A Phase 1 study, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01134341: Completed Phase 1 study, sponsored by Acrotech Biopharma.
NCT01134341 is a Phase 1 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01134341, a Phase 1 study, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This study is designed to determine the recommended dose, safety, pharmacokinetics, and early efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or refractory CTCL.
Primary Outcome
DLT rate is the number of patients experiencing a DLT divided by number of evaluable patients and it will be summarized by dose level.
Interventions
- DIETARY_SUPPLEMENT Vitamin B12
- DRUG Pralatrexate Injection
- DIETARY_SUPPLEMENT Folic Acid
- DRUG Bexarotene Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2010-03 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT01134341 record still lists
NCT01134341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 4 interventions - of which Vitamin B12 is the first listed.
NCT01134341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01134341 about?
NCT01134341 is a clinical study titled "Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma". This study is designed to determine the recommended dose, safety, pharmacokinetics, and early efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or refractory CTCL.
What is the current status of trial NCT01134341?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-03. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01134341?
The interventions under investigation include: Vitamin B12 (DIETARY_SUPPLEMENT), Pralatrexate Injection (DRUG), Folic Acid (DIETARY_SUPPLEMENT), Bexarotene Capsules (DRUG).
Who is sponsoring clinical trial NCT01134341?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01134341's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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