INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myelop… (NCT01164163) | Clinical Trial Compass
CompletedPhase 1
INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease
United States49 participantsStarted 2010-09
Plain-language summary
RATIONALE: INCB18424 (Ruxolitinib) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase 1 clinical trial is studying the side effects and best dose of INCB18424 in treating young patients with relapsed or refractory solid tumor, leukemia, or myeloproliferative disease.
Who can participate
Age range1 Year – 21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of one of the following:
* Relapsed or refractory extracranial solid tumor
* Relapsed or refractory leukemia
* At least 25% blasts in the bone marrow (M3) with the exception of patients with acute myeloid leukemia (AML), who must have \> 20% blasts in the bone marrow
* Relapsed or refractory myeloproliferative neoplasm (MPN)
* At original diagnosis or relapse
* Current diagnostic criteria for MPNs include polycythemia vera, essential thrombocythemia, juvenile myelomonocytic leukemia, myelofibrosis, and atypical chronic myeloid leukemia
* Relapsed or refractory leukemia or MPN that have confirmed JAK mutations and/or positive TSLPR surface staining
* Testing for JAK mutations and/or confirmed positive flow cytometry surface staining for the thymic stromal lymphopoietin receptor (TSLPR; encoded by CRLF2); eligibility for part C will be contingent upon patients demonstrating overexpression of CRLF2 by flow cytometric methods measured at either JHU or U. Washington flow laboratories (therefore, pre-enrollment samples need to be sent to one of these laboratories after discussion with Dr. Loh) or if the patient has a CLIA lab documented alteration in JAK1 or JAK2, SH2B3, IL7RA, or another gene that would predict sensitivity to JAK inhibition.
* Measurable or evaluable disease (for patients with solid tumors)
* Current disease state is one for which there is no known curative therapy or therap…
What they're measuring
1
Maximum-tolerated dose and/or recommended phase II dose