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NCT01998035 · ClinicalTrials.gov registry record · Phase 1
Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies
A Phase 1 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT01998035 is a Phase 1 study that was terminated before completion, run by Columbia University. The registered enrollment target is 58 participants.
The verdict
NCT01998035, a Phase 1 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I followed by a disease focused phase II. The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. The safety and toxicity of this combination will be evaluated throughout the entire study. If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is established, the phase II part of the study will be initiated. Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and romidepsin for patients with relapsed or refractory T-cell lymphomas.
Interventions
- DRUG RomiDEPsin 10 MG/M2
- DRUG Oral 5-Azacitidine 100 MG
- DRUG Romidepsin 14 MG/M2
- DRUG Oral 5-Azacitidine 200 MG
- DRUG Oral 5-Azacitidine 300 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2013-11 |
| Est. Completion | 2020-01-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01998035
The ClinicalTrials.gov registry entry for NCT01998035 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which RomiDEPsin 10 MG/M2 is the first listed.
NCT01998035 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01998035 about?
NCT01998035 is a clinical study titled "Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies". This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I followed by a disease focused phase II. The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romide...
What is the current status of trial NCT01998035?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2013-11. Estimated completion is 2020-01-06.
What interventions are being tested in trial NCT01998035?
The interventions under investigation include: RomiDEPsin 10 MG/M2 (DRUG), Oral 5-Azacitidine 100 MG (DRUG), Romidepsin 14 MG/M2 (DRUG), Oral 5-Azacitidine 200 MG (DRUG), Oral 5-Azacitidine 300 MG (DRUG).
Who is sponsoring clinical trial NCT01998035?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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