A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Study ID
- NCT01776723
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Myelomonocytic Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ruxolitinib — DRUGIn Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.
Study Details
The purpose of this study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug \[ruxolitinib\] can improve outcomes of patients with CMML. The first step of the study is to learn the dose of ruxolitinib that is tolerable (bearable). It has already been studied in a number of patients with different bone marrow diseases and is approved for the treatment of a disease called Myelofibrosis; however, it is not approved for treatment of CMML. It is given orally (by mouth). Most people tolerate it well but the tolerability has not been determined in patients with CMML. We will be testing different doses to determine how much of the medication people can tolerate (bear) before they develop side effects.
Key Dates
- Start date
- Feb 20, 2013
- Status verified
- Sep 2022
- Primary completion
- Nov 28, 2018
- Completion
- May 10, 2022
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: I: Dose Escalation - RuxolitinibPhase I: Dose Escalation. In Phase I, participants will be allocated to dose levels starting at 10 mg/d (twice a day \[BID\] dosing) according to the "rolling six" Phase I design.
- Experimental: II: Maximum Tolerated Dose - RuxolitinibPhase II: Treatment at Maximum Tolerated Dose (MTD).
Primary Outcome Measure
The Maximum Tolerated Dose (MTD) of Ruxolitinib for the Treatment of Myelomonocytic Leukemia (CMML) [ Time Frame: 17 weeks ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | - |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | - |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | - |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| Weill Medical College of Cornell | New York | New York | 10021 | - |
| Cleveland Clinic | Cleveland | Ohio | 44106 | - |