A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib (FREEDOM)

December 11, 2024 updated by: Celgene

A Phase 3b, Multicenter, Single-Arm, Open-Label Efficacy and Safety Study of Fedratinib in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib

This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (post-ET MF) and Previously Treated with Ruxolitinib.

The primary objective of the study is to evaluate the percentage of subjects with at least a 35% reduction in spleen size and one of the secondary objectives is to evaluate the safety of fedratinib.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (post-ET MF) and Previously Treated with Ruxolitinib.

The spleen volume reduction at the end of Cycle 6 as the primary objective. The secondary objectives of the study are to further evaluate the safety and to assess and implement mitigation strategies for WE and for gastrointestinal (GI) adverse events.

The study will be at multiple centers to provide access to a broad population and have assurance the results are likely to have general applicability.

This is also conducted as an open-label study to collect efficacy and safety data with fedratinib use, no randomization or stratification will occur.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2A5
        • Local Institution - 203
    • Ontario
      • London, Ontario, Canada, N6C 6B5
        • Local Institution - 207
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 205
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 200
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 202
      • Montreal, Quebec, Canada, H1T 2M4
        • Local Institution - 201
      • Sherbrooke, Quebec, Canada, J1K 2R1
        • Local Institution - 204
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 117
    • Florida
      • Miami, Florida, United States, 33176
        • Local Institution - 126
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Local Institution - 113
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Local Institution - 112
      • Chicago, Illinois, United States, 60637
        • Local Institution - 109
      • Park Ridge, Illinois, United States, 60068
        • Local Institution - 121
    • Kansas
      • Kansas City, Kansas, United States, 66160-7314
        • Local Institution - 100
    • Maryland
      • Baltimore, Maryland, United States, 21229-5299
        • Local Institution - 123
      • Bethesda, Maryland, United States, 20817
        • Local Institution - 118
      • Columbia, Maryland, United States, 21044
        • Local Institution - 127
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 103
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 101
    • New Jersey
      • Newark, New Jersey, United States, 07112-2027
        • Local Institution - 128
    • New York
      • Brooklyn, New York, United States, 11212
        • Local Institution - 130
      • New York, New York, United States, 10029
        • Local Institution - 115
      • New York, New York, United States, 10032
        • Local Institution - 124
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Local Institution - 105
      • Durham, North Carolina, United States, 27705
        • Local Institution - 114
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Local Institution - 111
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Local Institution - 106
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Local Institution - 108
    • Texas
      • Dallas, Texas, United States, 75390-8852
        • Local Institution - 119
      • Fort Worth, Texas, United States, 76104
        • Local Institution - 132
      • Houston, Texas, United States, 77303
        • Local Institution - 110
      • San Antonio, Texas, United States, 78229
        • Local Institution - 120
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 116
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-2454
        • Local Institution - 129

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Main Study Inclusion Criteria

  1. Subject is at least 18 years of age at the time of signing the informed consent form (ICF)
  2. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2
  3. Subject has diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-ET or post-PV myelofibrosis according to the IWG-MRT 2007 criteria, confirmed by the most recent local pathology report
  4. Subject has a DIPSS Risk score of Intermediate or High
  5. Subject has a measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥ 450 cm3 by MRI or CT-scan assessment or by palpable spleen measuring ≥ 5 cm below the left costal margin.

  6. Subject has been previously exposed to ruxolitinib, while diagnosed with MF (PMF, post-ET MF or post-PV MF), and must meet at least one of the following criteria (a or b)

    1. Treatment with ruxolitinib for ≥ 3 months

    2. Treatment with ruxolitinib for ≥ 28 days complicated by any of the following:

      • Development of a red blood cell transfusion requirement (at least 2 units/month for 2 months) or
      • Grade ≥ 3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while on treatment with ruxolitinib
  7. Subject must have treatment-related toxicities from prior therapy resolved to Grade 1 or pretreatment baseline before start of last therapy prior to fedratinib treatment.
  8. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted
  9. Subject is willing and able to adhere to the study visit schedule and other protocol requirements
  10. Participants must agree to use effective contraception

Exclusion Criteria:

Main Study Exclusion Criteria

  1. Any of the following laboratory abnormalities:

    1. Platelets < 50,000/μL
    2. Absolute neutrophil count (ANC) < 1.0 x 109/L
    3. White blood count (WBC) > 100 x 10^9/L
    4. Myeloblasts > 5 % in peripheral blood
    5. Estimated glomerular filtration rate < 30 mL/min/1.73 m^2 (as per the Modification of Diet in Renal Disease [MDRD] formula)
    6. Serum amylase or lipase > 1.5 x ULN (upper limit of normal)
    7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x ULN
    8. Total bilirubin > 1.5 x ULN, subject's total bilirubin between 1.5 - 3.0 x ULN are eligible if the direct bilirubin fraction is < 25% of the total bilirubin
  2. Subject is pregnant or lactating female
  3. Subject with previous splenectomy
  4. Subject with previous or planned hematopoietic cell transplant
  5. Subject with prior history of encephalopathy, including Wernicke's
  6. Subject with signs or symptoms of encephalopathy including Wernicke's (eg, severe ataxia, ocular paralysis or cerebellar signs)
  7. Subject with thiamine deficiency, defined as thiamine levels in whole blood below normal range according to institutional standard and not corrected prior to enrollment on the study
  8. Subject with concomitant treatment with or use of pharmaceutical, herbal agents or food known to be strong or moderate inducers of Cytochrome P450 3A4 (CYP3A4), or dual CYP2C19 and CYP3A4 inhibitors
  9. Subject on any chemotherapy, immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), anagrelide, immunosuppressive therapy, systemic corticosteroids > 10 mg/day prednisone or equivalent. Subjects who have had prior exposure to hydroxyurea (eg, Hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to the start of fedratinib treatment
  10. Subject has received ruxolitinib within 14 days prior to the start of fedratinib
  11. Subject on treatment with myeloid growth factor (eg, granulocyte-colony stimulating factor [G-CSF]) within 14 days prior to the start of fedratinib treatment
  12. Subject with previous exposure to Janus kinase (JAK) inhibitor(s) for more than 1 cycle other than ruxolitinib treatment
  13. Subject on treatment with aspirin with doses > 150 mg daily
  14. Subject with major surgery within 28 days before starting fedratinib treatment
  15. Subject with diagnosis of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemochromatosis, non-alcoholic steatohepatitis)

  16. Subject with prior malignancy other than the disease under study unless the subject has not required treatment for the malignancy for at least 3 years prior to enrollment.

    However, subject with the following history/concurrent conditions provided successfully treated may enroll: non-invasive skin cancer, in situ cervical cancer, carcinoma in situ of the breast, incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system), or is free of disease and on hormonal treatment only

  17. Subject with uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4)
  18. Subject with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC)
  19. Subject with serious active infection
  20. Subject with presence of any significant gastric or other disorder that would inhibit absorption of oral medication
  21. Subject is unable to swallow capsule
  22. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  23. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  24. Subject has any condition that confounds the ability to interpret data from the study
  25. Subject with participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to start of fedratinib treatment
  26. Subject with life expectancy of less than 6 months.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Administration of Fedratinib 400mg/day
Self-administered Investigational Product (IP) (400 mg/day) on an outpatient basis, once daily preferably with food during an evening meal at the same time each day in consecutive 4-week (28-day) cycles.
Drug: FEDRATINIB
A potent and selective inhibitor of JAK2 kinase activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Have a ≥ 35% Spleen Volume Reduction (SVR) at End of Cycle 6
Time Frame: From First Dose to end of Cycle 6 (approximately 168 days)
Percentage of participants who have a ≥ 35% SVR at end of Cycle 6 as compared to baseline. Participants with a missing MRI/CT spleen volume at the end of Cycle 6 including those who meet the criteria for progression of splenomegaly before the end of Cycle 6 will be considered non-responders. Baseline value is defined as the last value or measurement taken prior to the first dose in the study
From First Dose to end of Cycle 6 (approximately 168 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants of All Grade Adverse Events (AEs) and Grade 3/4 AEs
Time Frame: From first dose up to 30 days post last dose. (an average of 50.3 weeks up to a maximum of 128 weeks)
Number of participants and severity of all grade adverse events (AEs) and grade 3/4 AEs as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.
From first dose up to 30 days post last dose. (an average of 50.3 weeks up to a maximum of 128 weeks)
Number of Participants and Severity of Treatment Related All Grade Adverse Events (AEs) and Grade 3/4 AEs
Time Frame: From first dose up to 30 days post last dose. (an average of 50.3 weeks up to a maximum of 124 weeks)
Number of participants and severity of treatment related all grade adverse events (AEs) and grade 3/4 AEs as per NCI CTCAE.
From first dose up to 30 days post last dose. (an average of 50.3 weeks up to a maximum of 124 weeks)
Mean Change From Baseline in Hematology Laboratory Analysis - Hemoglobin
Time Frame: at Cycle 4 Day 1 and Cycle 7 Day 1
Mean change from baseline in hematology laboratory analysis - hemoglobin
at Cycle 4 Day 1 and Cycle 7 Day 1
Mean Change From Baseline in Hematology Laboratory Analysis - Erythrocytes
Time Frame: at Cycle 4 Day 1 and Cycle 7 Day 1

Mean change from baseline in hematology laboratory analysis - erythrocytes.

Baseline value is defined as the last value or measurement taken prior to the first dose in the study
at Cycle 4 Day 1 and Cycle 7 Day 1
Mean Change From Baseline in Hematology Laboratory Analysis - Platelets, Leukocytes and Neutrophils
Time Frame: at Cycle 4 Day 1 and Cycle 7 Day 1

Mean change from baseline in hematology laboratory analysis - platelets, leukocytes and neutrophils.

Baseline value is defined as the last value or measurement taken prior to the first dose in the study
at Cycle 4 Day 1 and Cycle 7 Day 1
Mean Change From Baseline in the Percentage of Blasts/Leukocytes in Hematology Laboratory Analysis
Time Frame: at Cycle 4 Day 1 and Cycle 7 Day 1

Mean change from baseline in hematology laboratory analysis - blasts/leukocytes

Baseline value is defined as the last value or measurement taken prior to the first dose in the study
at Cycle 4 Day 1 and Cycle 7 Day 1
Mean Change From Baseline in Chemistry Parameters Analysis - ALT, AST, Amylase, Lipase
Time Frame: at Cycle 4 Day 1 and Cycle 7 Day 1

Mean change from baseline in chemistry parameters analysis - ALT, AST, Amylase, Lipase

Baseline value is defined as the last value or measurement taken prior to the first dose in the study
at Cycle 4 Day 1 and Cycle 7 Day 1
Mean Change From Baseline in Chemistry Parameters Analysis - Creatinine
Time Frame: at Cycle 4 Day 1 and Cycle 7 Day 1

Mean change from baseline in chemistry parameters analysis - Creatinine.

Baseline value is defined as the last value or measurement taken prior to the first dose in the study
at Cycle 4 Day 1 and Cycle 7 Day 1
Spleen Response Rate by Palpation
Time Frame: From First Dose to end of Cycle 6 (approximately 168 days)
Spleen response rate by palpation is the percentage of participants with a spleen response according to the IWG-MRT 2013 at the end of Cycle 6 as compared to baseline. This will be calculated for participants that have an enlarged spleen (≥ 5 cm below LCM) at baseline. Participants with a missing spleen size assessment at the end of Cycle 6 including those who meet the criteria for progression of splenomegaly before the end of Cycle 6 will be considered not to be responders.
From First Dose to end of Cycle 6 (approximately 168 days)
Symptom Response Rate
Time Frame: From First Dose to end of Cycle 6 (approximately 168 days)
Symptom response rate (SRR) is defined as the percentage of participants with ≥ 50% reduction from baseline to the end of Cycle 6 in total symptom score (TSS) measured by MFSAF version 4.0. The TSS will be defined as the sum of each of the 7 symptom scores. Participants without a baseline TSS > 0 will be considered non-evaluable (due to no place for symptom reduction) for the SRR analysis. Participants with a missing TSS at the end of Cycle 6 or who had disease progression before the end of the Cycle 6 will be considered non-responders.
From First Dose to end of Cycle 6 (approximately 168 days)
Number of Participants With Grade 3 or Higher AEs: Nausea, Vomiting, Diarrhea and Encephalopathy Including Wernicke's.
Time Frame: From first dose to end of treatment (an average of 50.3 weeks up to a maximum of 124 weeks)
Number of participants with grade 3 or higher AEs: Nausea, Vomiting, Diarrhea and Encephalopathy including Wernicke's.
From first dose to end of treatment (an average of 50.3 weeks up to a maximum of 124 weeks)
Durability of Spleen Volume Response by MRI/CT (DR)
Time Frame: From Cycle 1 Day 1 up to 30 days after last dose (Approximately an average of 59.40 Weeks)
Durability of spleen volume response (DR) by MRI/CT is defined as time from the first documented spleen response (ie, ≥ 35% reduction in spleen volume) to the date of subsequent progressive disease (PD) (ie, ≥ 25% increase in spleen volume from baseline) or death, whichever is earlier. In the absence an event (ie, subsequent spleen volume reduction < 35% before the analysis is performed), the DR will be censored at the date of the last valid assessment performed before the analysis performed date. Durability of spleen volume response by MRI/CT scan will be analyzed using Kaplan-Meier method.
From Cycle 1 Day 1 up to 30 days after last dose (Approximately an average of 59.40 Weeks)
Durability of Spleen Response by Palpation (DRP)
Time Frame: From Cycle 1 Day 1 up to 30 days after last dose (Approximately an average of 59.32 Weeks)
Durability of spleen response by palpation (DRP) is defined as time from the date of first documented palpable spleen response, according to the IWG-MRT 2013 to the date of subsequent PD according to the IWG-MRT 2013 or death, whichever is earlier. Durability of spleen response by palpation according to the IWG-MRT 2013 criteria will be calculated for subjects that have an enlarged spleen at baseline (≥ 5 cm below LCM), and that have a spleen response by palpation. In the absence of an event (ie, no loss of spleen response by palpation) before the analysis is performed, the DRP will be censored at the date of the last valid assessment performed before the analysis performed date. Durability of spleen response by palpation will be analyzed using Kaplan-Meier (K-M) method.
From Cycle 1 Day 1 up to 30 days after last dose (Approximately an average of 59.32 Weeks)
Durability of Symptom Response (DSR)
Time Frame: From Cycle 1 Day 1 up to 30 days after last dose (Approximately an average of 31.33 Weeks)
Durability of symptoms response is defined as time from the first documented response in TSS (ie, reduction in TSS ≥ 50%) measured by MFSAF version 4.0 to the first documented TSS reduction < 50%. In the absence of TSS reduction < 50% before the analysis performed, the DSR will be censored at the date of the last valid assessment performed before the analysis performed date.
From Cycle 1 Day 1 up to 30 days after last dose (Approximately an average of 31.33 Weeks)
Number of Participants With Thiamine Levels < Lower Limit of Normal (LLN).
Time Frame: At Cycle 1, 2, 3, and every 3 cycles afterwards till End of Treatment (an average of 50.3 weeks up to a maximum of 124 weeks)

Number of participants with thiamine levels < LLN.

LLN of thiamine is 70 nmol/L.
At Cycle 1, 2, 3, and every 3 cycles afterwards till End of Treatment (an average of 50.3 weeks up to a maximum of 124 weeks)
Number of Participants With Thiamine Levels > Upper Limit of Normal (ULN).
Time Frame: At Cycle 1, 2, 3, and every 3 cycles afterwards till End of Treatment (an average of 50.3 weeks up to a maximum of 124 weeks)

Number of participants with thiamine levels > ULN.

ULN of thiamine is 180 nmol/L.
At Cycle 1, 2, 3, and every 3 cycles afterwards till End of Treatment (an average of 50.3 weeks up to a maximum of 124 weeks)
Number of Participants With Clinically Notable Laboratory Results, Grade 3 or 4
Time Frame: From first dose up to 30 days post last dose. (an average of 50.3 weeks up to a maximum of 124 weeks)
Number of participants with clinically notable laboratory results, Grade 3 or 4
From first dose up to 30 days post last dose. (an average of 50.3 weeks up to a maximum of 124 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FEDR-MF-001
  • U1111-1223-2862 (Other Identifier: WHO)
  • 2018-002237-38 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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