Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01633372
Registration number
NCT01633372
Ethics application status
Date submitted
26/06/2012
Date registered
4/07/2012
Date last updated
30/08/2021
Titles & IDs
Public title
An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis
Query!
Scientific title
An Open-Label, Multiple Simon 2-Stage Study of Itacitinib Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF)
Query!
Secondary ID [1]
0
0
INCB 39110-230
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
MPN (Myeloproliferative Neoplasms)
0
0
Query!
Condition category
Condition code
Blood
0
0
0
0
Query!
Haematological diseases
Query!
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - itacitinib
Experimental: itacitinib 100 mg - itacitinib 100 mg twice a day
Experimental: itacitinib 200 mg - itacitinib 200 mg twice a day
Experimental: itacitinib 300 mg - itacitinib 300 mg once a day
Experimental: itacitinib 400 mg - itacitinib 400 mg once a day
Experimental: itacitinib 600 mg - itacitinib 600 mg once a day
Treatment: Drugs: itacitinib
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of subjects with >/= 50% reduction in total symptom score in each dose group, as measured by the modified The Myelofibrosis Symptom Assessment Form (MFSAF) v3.0 diary
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline and Week 12
Query!
Secondary outcome [1]
0
0
Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline, Week 12 and Week 24
Query!
Secondary outcome [2]
0
0
Proportion of transfusion dependent subjects who exhibit changes in transfusion frequency over any 12 week period on study and proportion of transfusion independent subjects who exhibit changes in hemoglobin level
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Baseline to Week 12; Week 13 to Week 24 through the end of study or study termination visit.
Query!
Secondary outcome [3]
0
0
Safety and tolerability of itacitinib as measured by adverse events.
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase).
Query!
Eligibility
Key inclusion criteria
- Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy.
- Must score at least 1 point on the Dynamic International Prognostic Scoring System
(DIPSS) for prognostic risk factors and have peripheral blast count <10% at both
Screening and Baseline hematology assessments.
- Subjects must discontinue all drugs used to treat underlying MF disease no later than
Day -14.
- Subjects must have hemoglobin value >/= 8.0g/dL and be willing to receive blood
transfusions, have a platelet count >/=50x10^9/L and absolute neutrophil count (ANC)
>/= 1x10^9/L.
- Subjects must have palpable spleen or history of splenectomy
- Active symptoms at the screening visit
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Women who are pregnant or breastfeeding, and men and women who cannot comply with
requirements to avoid fathering a child or becoming pregnant, respectively.
- Subjects with impaired liver function, end stage renal disease on dialysis or
clinically significant concurrent infections requiring therapy.
- Subjects with unstable cardiac function or invasive malignancies over the previous 2
years except treated basal or squamous carcinomas of the skin, completely resected
intraepithelial carcinoma of the cervix and completely resected papillary thyroid and
follicular thyroid cancers.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/07/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
29/06/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
87
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
St Vincent's Hospital - Darlinghurst
Query!
Recruitment hospital [2]
0
0
St. George Hospital - Kogarah
Query!
Recruitment hospital [3]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [4]
0
0
Frankston Hospital - Frankston
Query!
Recruitment postcode(s) [1]
0
0
- Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
- Kogarah
Query!
Recruitment postcode(s) [3]
0
0
- Box Hill
Query!
Recruitment postcode(s) [4]
0
0
- Frankston
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New York
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Oregon
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
South Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Alberta
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
British Columbia
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Quebec
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Incyte Corporation
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will
evaluate safety and efficacy parameters of itacitinib (INCB039110).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01633372
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Albert Assad, MD
Query!
Address
0
0
Incyte Corporation
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01633372
Download to PDF