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Clinical Trial 19659

Cancer Type: Malignant Hematology
Interventions:INCB053914; Jakafi (Ruxolitinib); Ruxolitinib

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Andrew Kuykendall

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies

Summary

Objective

Primary Objectives: All parts: To evaluate the safety and tolerability of INCB053914 as a monotherapy and in combination with standard-of-care (SOC) agents in subjects with advanced malignancies. Part 4 only: - To evaluate the efficacy of INCB053914 in combination with cytarabine in subjects with relapsed or refractory acute myeloid leukemia (AML) based on objective remission rate (ORR). - To evaluate the efficacy of INCB053914 in combination with azacitidine in subjects with newly diagnosed AML who are 65 years or older and unfit for intensive chemotherapy based on ORR. Secondary Objectives: All parts: To evaluate the pharmacokinetics (PK) of INCB053914 when administered alone in the fasted state, the effect of food on the INCB053914 PK, and the PK when administered in combination with SOC agents in the fasted state. All parts: To assess the pharmacodynamics (PD) of INCB053914 as a monotherapy and in combination with SOC agents in subjects with advanced malignancies. All parts: To evaluate preliminary efficacy of INCB053914 as a monotherapy and in combination with SOC agents in subjects with advanced malignancies based on response criteria applicable for each disease. - Part 4 only: To evaluate the efficacy of INCB053914 in combination with ruxolitinib on spleen volume reduction in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF), or post essential thrombocythemia myelofibrosis (PET-MF).

Inclusion Criteria

  • Aged 18 years or older
  • Confirmed diagnosis of select advanced malignancy
  • Parts 1 and 2: Unresponsive to currently available therapy and there is no standard-of-care therapy available in the judgment of the investigator. Not currently a candidate for curative treatment
  • Parts 3 and 4: Subjects with relapsed/refractory AML must have received either induction chemotherapy for AML or hypomethylating agents for hematologic disease before AML. Elderly subjects (≥ 65 years) with newly diagnosed AML must be treatment naive and unfit for intensive chemotherapy. Myelofibrosis subjects must have been treated with ruxolitinib at a stable dose for ≥ 8 weeks. One dose reduction due to toxicities within 8 weeks before Study Day 1 will be permitted. Acceptable doses are 5 mg twice daily (BID) to 25 mg BID. OD doses are not allowed.
  • Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate, or archival sample obtained since completion of most recent therapy (as appropriate to subjects with existing bone marrow disease or for whom bone marrow examination is a component of disease status assessment)

  • Exclusion Criteria

  • Inadequate bone marrow or organ function
  • Received an investigational agent within 5 half-lives or 14 days, whichever is longer, prior to receiving the first dose of study drug
  • Received non-biologic anticancer medication within 5 half-lives prior to receiving the first dose of study drug (within 6 weeks for mitomycin-C or nitrosoureas), within 28 days for any antibodies or biological therapies
  • Prior receipt of a PIM inhibitor
  • Any history of disease involving the central nervous system (Part 1). Known active disease involving the central nervous system (Part 2).
  • Screening corrected QT interval (QTc) interval > 470 milliseconds
  • Radiotherapy within the 2 weeks prior to initiation of treatment
  • Chronic or current active infection requiring systemic antibiotic, antifungal, or antiviral treatment