INCB018424 in Patients With Advanced Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00674479
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : March 29, 2017
Incyte Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if ruxolitinib can help to control advanced hematological malignancies. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Chronic Myelogenous Leukemia Drug: INCB018424 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of INCB018424 in Patients With Advanced Hematologic Malignancies
Actual Study Start Date : May 12, 2008
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

Arm Intervention/treatment
Experimental: INCB018424
The starting dose of INCB018424 will be 25 mg by mouth twice daily.
Drug: INCB018424
Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks.

Primary Outcome Measures :
  1. Response Rate [ Time Frame: Patients will be evaluated after each full cycle of therapy (28 days) for response. ]
    Survival, time to progression, time to treatment failure, and duration of response will be presented using Kaplan-Meier curves for each patient group. "Time of Response " defined as the period of time from the date of first study drug administration until the first objective documentation of response.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Must be at least 18 years of age.
  2. Patients must have relapsed/refractory leukemias for which no standard therapies exist. Patients with poor-risk myelodysplasia (MDS) and chronic myelomonocytic leukemia (CMML) who failed prior therapy are also candidates for this protocol. Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by World Health Organization (WHO) classification (i.e. >/= 20% blasts), acute lymphocytic leukemia (ALL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with CML who are resistant to at least two tyrosine kinase inhibitors and have no standard stem cell transplant option are also eligible.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  4. A female of childbearing potential must have a negative serum or urine pregnancy test at screening. Women of child-bearing potential must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.
  5. Must be able and willing to give written informed consent.
  6. In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least one week for noncytotoxic agents. Persistent clinically significant toxicities from prior chemotherapy must not be greater than grade 2.
  7. Patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: 1.) Serum creatinine less than or equal to 2.0 mg/dl. 2.) Total bilirubin less than or equal to 1.5x the upper limit of normal unless considered due to Gilbert's syndrome or hemolysis. 3.) Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 2.5x the upper limit of normal unless considered due to organ leukemic involvement (then 5x).
  8. Patients with active central nervous system (CNS) disease are included and will be treated concurrently with intrathecal therapy. INCB018424 will not be administered by intrathecal route.

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  2. Active heart disease including myocardial infarction within the previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
  3. Current treatment or treatment within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational drug protocol (unless there is evidence of rapidly progressive disease in which case a shorter interval from last therapy may be acceptable).
  4. Females who are pregnant or are currently breastfeeding.
  5. Patients receiving therapy with intermediate or high dose steroids greater than the equivalent of 10 mg prednisone per day are not allowed.
  6. Evidence of active hepatitis or human immunodeficiency virus (HIV) infection determined by screening laboratory test results or results within prior 3 months.
  7. Any unresolved toxicity equal to or greater than Grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity.
  8. Incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry, excluding the placement of vascular access.
  9. Uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
  10. In patients who are receiving medications known to be inhibitors or inducers of CYP3A4 every effort will be made to change these medications to acceptable alternatives. If this is not safely possible, patients will be excluded from participation in the study. If a patient is already on the study, must be started on a CYP3A4 inhibitor, and is demonstrating benefit from the study, they will be seen twice weekly in the first cycle and weekly in the subsequent cycles for toxicity evaluation and their dose will be modified in the event of a toxicity related to the study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00674479

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Incyte Corporation
Principal Investigator: Farhad Ravandi-Kashani, M.D. M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00674479     History of Changes
Other Study ID Numbers: 2007-0925
NCI-2012-01616 ( Registry Identifier: NCI CTRP )
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Advanced Hematologic Malignancies
Bone marrow
Lymph nodes
JAK kinase inhibitor INCB018424 phosphate
Acute Myeloid Leukemia
Acute Lymphocytic leukemia
Myelodysplastic Syndrome
Chronic myelogenous leukemia - Blast Crisis

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders