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NCT01702064 · ClinicalTrials.gov registry record · Phase 1

Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
11
Enrollment target

NCT01702064: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT01702064 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01702064, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
11 participants
Enrollment target

Study Summary

This study is designed to determine the maximal tolerated dose of Ruxolitinib in combination with nilotinib in patients with chronic myeloid leukemia (CML).

Primary Outcome

Maximum tolerated dose (MTD) of ruxolitinib with nilotinib. Dose escalation will follow a 3+3 study design. If 2 or more participants within a cohort experience a dose limiting toxicity (DLT), then the MTD will have been exceeded and the preceding dose level will be evaluated as the MTD. A minimum of 6 participants must be evaluated at the dose level in order for it to be declared as the MTD. Dose limiting toxicity is defined as: * Any non-hematological toxicity ≥ grade three, excluding any un

Interventions

  • DRUG Ruxolitinib
  • DRUG Nilotinib

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2013-02-21
Est. Completion 2019-01-09
Phase Phase 1

What the finished NCT01702064 record still lists

NCT01702064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Ruxolitinib is the first listed.

NCT01702064 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01702064 about?

NCT01702064 is a clinical study titled "Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients". This study is designed to determine the maximal tolerated dose of Ruxolitinib in combination with nilotinib in patients with chronic myeloid leukemia (CML).

What is the current status of trial NCT01702064?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2013-02-21. Estimated completion is 2019-01-09.

What interventions are being tested in trial NCT01702064?

The interventions under investigation include: Ruxolitinib (DRUG), Nilotinib (DRUG).

Who is sponsoring clinical trial NCT01702064?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01702064's enrollment target sits among peer trials

11 1911th of 2000 higher than 88 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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Source: ClinicalTrials.gov NCT01702064, the US trial registry maintained by the National Library of Medicine. NCT01702064 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.