- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01822691
Phase II INCB024360 Study for Patients With Myelodysplastic Syndromes (MDS)
December 14, 2015 updated by: H. Lee Moffitt Cancer Center and Research Institute
A Phase II Study to Determine the Safety and Efficacy of INCB024360 in Patients With Myelodysplastic Syndromes
The primary purpose of this research study is to assess whether the participant's disease, Myelodysplastic Syndromes (MDS), responds favorably to INCB024360.
The study will also evaluate the long-term outcomes of the participant's disease after they have finished taking INCB024360.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of myelodysplastic syndromes (MDS)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate organ function:
- Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN)
- Aspartic transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 × ULN
- Creatinine ≤ 2 × ULN or Creatinine clearance of > 30 mL/min (using the Cockcroft and Gault Equation)
- Females of childbearing potential must have a negative urine or serum pregnancy test at Screening.
- Women of child-bearing potential and men must agree to use adequate contraception (surgical tubal ligation or vasectomy, double-barrier method of birth control condom with spermicide in conjunction with use of an intrauterine device (IUD) or diaphragm; or sexual abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant, or a male impregnate his female partner, while participating in this study, he/she should inform their treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Prior MDS therapy within 4 weeks of the first dose of study medication. For erythroid stimulating agent and growth factors: prior therapy with epoetin (Procrit) or G-CSF (neupogen) or GM-CSF (leukine) within 2 weeks of the first dose of study medication.
- Has participated in any other trial in which receipt of an investigational study drug occurred within 28 days.
- Has undergone a stem cell, bone marrow or solid organ transplant.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit by the investigator opinion compliance with study requirements
History of hepatitis or positive serology as follows:
- Hepatitis B (HepB) screening testing required: HepB SAg (hepatitis B surface antigen); Anti-HepB SAg (antibody against hepatitis B surface antigen); Anti-Hepatitis B core IgG (antibody against hepatitis B core antigen); Anti-Hepatitis B core IgM antibody Note: Subjects with no prior history of hepatitis B infection who have been vaccinated against hepatitis B and who have a positive anti-HepB SAg test as the only evidence of prior exposure may participate in the trial.
- Hepatitis C screening required: antibody against hepatitis C virus (HCV-antibody); HCV-RNA (serum test for circulating virus, based on detecting RNA)
- Known history human immunodeficiency virus (HIV)
- Is receiving any compound that is known to be a potent inducer or inhibitor of CYP3A4
- Being treated with a monoamine oxidase inhibitor (MAOI), or drug which has significant monoamine oxidase inhibitory activity (meperidine, linezolid, methylene blue) within 3 weeks prior to screening
- Has, by the investigator assessment, an active autoimmune process such as rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc. or is receiving therapy for an autoimmune disease. Subjects with vitiligo, hypothyroidism or eczema may be enrolled after approval by the sponsor.
- Receiving any immunologically based treatment for any reason, including chronic use of systemic steroid at doses ≥ 7.5 mg/day prednisone equivalents; use of inhaled or topical steroids is acceptable.
- Prior malignancies other than MDS for which the subject has not been disease free for ≤ 3 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.
- Use of any UGT1A9 inhibitor including: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid from screening through follow-up period.
- Have had prior Serotonin Syndrome
- Any unresolved toxicity greater than Grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: INCB024360 Treatment
Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
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INCB024360 is an inhibitor of the enzyme indoleamine 2,3-dioxygenase (IDO) that is proposed for development for the treatment of malignant diseases.
Participants were to receive the study drug in 28 day (4 week) cycles of treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: Up to 12 months
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ORR, measured by Response Criteria for Patients with Myelodysplastic Syndrome (MDS).
According International Working Group (IWG) 2006 criteria (Cheson et al, 2006).
Complete Remission (CR), Partial Remission (PR), Marrow CR, and Hematological Improvement (HI)(any cell line).
Stable Disease (SD): Failure to achieve at least PR, but no evidence of progression for > 8 weeks.
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Up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Time to Acute Myeloid Leukemia (AML) Progression
Time Frame: Up to 12 months
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Disease progression defined as progression to int-2 or high risk International Prognostic Scoring System (IPSS) score or AML, based on World Health Organization (WHO) AML Criteria.
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Up to 12 months
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Median Overall Survival (OS)
Time Frame: Up to 24 months
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Overall Survival (OS) defined as the time between the start of treatment and death.
Treatment Duration is 17 weeks plus optional continuation phase.
Study Duration is Treatment Phase followed by survival follow-up.
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Up to 24 months
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Number of Participants With Study Related Serious Adverse Events (SAEs)
Time Frame: Up to 12 months
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Participants with treatment emergent Grade 3 or 4 SAEs according to the NCI Common Terminology Criteria for Adverse Events Version (CTCAE) V4.0.
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Up to 12 months
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Number of Participants With Study Treatment Related Adverse Events (AEs)
Time Frame: Up to 12 months
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Participants with treatment emergent Other (not including serious) Adverse events.
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Up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
March 28, 2013
First Submitted That Met QC Criteria
April 1, 2013
First Posted (Estimate)
April 2, 2013
Study Record Updates
Last Update Posted (Estimate)
January 18, 2016
Last Update Submitted That Met QC Criteria
December 14, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-17280
- I-24360-12-01 (Other Grant/Funding Number: Incyte)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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