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NCT01712659 · ClinicalTrials.gov registry record · Phase 1
Ruxolitinib for Adult T-Cell Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01712659: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01712659 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01712659, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Background: * The human T-cell leukemia virus 1 (HTLV-1) causes adult T-cell leukemia (ATL). Infection does not immediately cause ATL, but it can develop over time. ATL is a rare and aggressive type of cancer that disrupts the body's ability to control the HTLV-1 virus. Infected T lymphocytes that are transformed by HTLV-1 into malignant ATL cell have constitutively activated Interleukin-2 (IL-2), IL-9 and IL-15 production pathways that function as autocrine and paracrine stimulators of these cells by stimulating these cells through the Janus Kinase (JAK) 1 and 3/Signal transducer and activator of transcription 5 (STAT5) pathways. * Ruxolitinib is a drug that has been approved to treat bone marrow disorders. Ruxolitinib is a tyrosine kinase inhibitor that disrupts signaling through the JAK 1 and 2/STAT3 and 5 pathways and have potential as a treatment for ATL. Researchers want to see if ruxolitinib can be a safe and effective treatment for ATL. * Initially this trial was designed as a single dose level phase II trial with ruxolitinib given at the dose approved for the treatment of primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. * Clinical and correlative laboratory data demonstrated limited inhibition and impact on the subject's disease with the standard 20 mg twice daily dose. Given that the manufacturers of ruxolitinib had safety data for administering ruxolitinib to normal healthy volunteers at doses up to 50 mg twice or 100 mg once daily, the trial was reconfigured as a phase I dose escalation trial giving these higher doses on the twice daily schedule Objectives: Initial Phase II design: * Define clinical or objective response rate for the 20 mg twice daily dose of Ruxolitinib. * Define safety profile, Time to progression and survival time. Subsequent Phase I dose escalation with expansion cohort treated at the MTD or MAD: * Determine the maximum tolerated dose (MTD) and clinical response rate
Interventions
- DRUG Ruxolitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-10-26 |
| Est. Completion | 2022-01-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01712659
The ClinicalTrials.gov registry entry for NCT01712659 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ruxolitinib is the first listed.
NCT01712659 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01712659 about?
NCT01712659 is a clinical study titled "Ruxolitinib for Adult T-Cell Leukemia". Background: * The human T-cell leukemia virus 1 (HTLV-1) causes adult T-cell leukemia (ATL). Infection does not immediately cause ATL, but it can develop over time. ATL is a rare and aggressive type of cancer that disrupts the body's ability to control the HTLV-1 virus. Infected T lymphocytes that ...
What is the current status of trial NCT01712659?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-10-26. Estimated completion is 2022-01-18.
What interventions are being tested in trial NCT01712659?
The interventions under investigation include: Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT01712659?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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