| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003123-42 | EudraCT Number |
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This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 : Dose Escalation of itacitinib | Experimental | Participants will be dosed at different dose levels with a maximum of up to 9 participants per dose level. |
|
| Part 2 : Dose Expansion of itacitinib | Experimental | Participants will be dosed at the recommended Phase 2 dose (RP2D) identified in Part 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| itacitinib | Drug | itacitinb Immediate Release (IR) will be dosed orally twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. | up to 724 days |
| Part 1: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | up to 724 days |
| Part 2: Splenic Response Rate (SRR) at Week 24 | SRR was defined as the percentage of participants who had a reduction in spleen volume (by imaging) of at least 35% when compared with Baseline. | Baseline; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Number of Participants With Any TEAE | An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University | New Orleans | Louisiana | 70112 | United States | ||
| Rcca Md, Llc |
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| Label | URL |
|---|---|
| Related Info | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted at 3 study centers in the United States and Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Itacitinib 300 mg | Participants received itacitinib immediate release 300 milligrams (mg) twice a day (BID) orally (PO) for at least 24 weeks. Participants could remain on treatment as long as they were receiving clinical benefit and had not met any criteria for treatment discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2022 |
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|
| up to at least 24 weeks |
| Part 2: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | up to at least 24 weeks |
| Part 2: Total Symptom Score (TSS) Response Rate at Week 24 | TSS response was defined as the percentage of participants who achieved at least 50% reduction in TSS over the 28 days immediately before the end of Week 24 compared with the 7 days immediately before the initiation of itacitinib immediate release (aseline).B | Baseline; Week 24 |
| Part 2: Mean Change (From Day 1 Versus Week 12 and Week 24) in the 5 Multi-item Functional Scale Scores and the Multi-item Global Health Status Scale Score (EORTC QLQ-C30) | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was to be used to assess the improvement in quality of life. | Baseline; Weeks 12 and 24 |
| Part 2: Percentage of Participants Categorized as Improved on the Week 24 Patient Global Impression of Change (PGIC) | The PGIC consists of a single question pertaining to a participant's overall status since the start of the study. The questionnaire gives participants 7 options to describe their overall status including: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. | Baseline; Week 24 |
| Bethesda |
| Maryland |
| 20817 |
| United States |
| Midamerica Cancer Care | Kansas City | Missouri | 64114 | United States |
| New Jersey Hematology Oncology Associates Llc | Brick | New Jersey | 08724-3009 | United States |
| Baptist Cancer Center | Memphis | Tennessee | 38120 | United States |
| Vanderbilt University | Nashville | Tennessee | 37235 | United States |
| Texas Oncology - Baylor Sammons Cancer Center | Dallas | Texas | 75246-2092 | United States |
| Renovatio Clinical Consultants Llc | Spring | Texas | 77380 | United States |
| Interne 1 - Hematologie Mit Stammzelltransplantation, Hemostaseologie Und Medizinische Onkologie Ord | Linz | 70376 | Austria |
| Cliniques Universitaires Ucl Saint-Luc | Brussels | 01000 | Belgium |
| Jessa Ziekenhuis | Hasselt | 03500 | Belgium |
| AZ DELTA | Roeselare | 08800 | Belgium |
| Chu Ucl Namur University Hospital Mont-Godinne | Yvoir | 05530 | Belgium |
| Universitaetsmedizin Greifswald | Greifswald | 17475 | Germany |
| Universitatsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele | Milan | 20132 | Italy |
| Aou San Giovanni Di Dio E Ruggi | Salerno | 84131 | Italy |
| Treviso Hospital | Treviso | 31100 | Italy |
| Pratia Hematologia Katowice | Katowice | 40-519 | Poland |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitari I Politecnic La Fe | Valencia | 46000 | Spain |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Itacitinib 300 mg | Participants received itacitinib immediate release 300 milligrams (mg) twice a day (BID) orally (PO) for at least 24 weeks. Participants could remain on treatment as long as they were receiving clinical benefit and had not met any criteria for treatment discontinuation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. | Safety Evaluable Population: all participants enrolled in the study who received at least 1 dose of study treatment | Posted | Count of Participants | Participants | up to 724 days |
|
|
| ||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | Safety Evaluable Population | Posted | Count of Participants | Participants | up to 724 days |
|
| |||||||||||||||||||||||||||
| Primary | Part 2: Splenic Response Rate (SRR) at Week 24 | SRR was defined as the percentage of participants who had a reduction in spleen volume (by imaging) of at least 35% when compared with Baseline. | Analysis was not conducted because Part 2 never opened for enrollment. | Posted | Baseline; Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 2: Number of Participants With Any TEAE | An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. | Analysis was not conducted because Part 2 never opened for enrollment. | Posted | up to at least 24 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 2: Number of Participants With Any Grade 3 or Higher TEAE | A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | Analysis was not conducted because Part 2 never opened for enrollment. | Posted | up to at least 24 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 2: Total Symptom Score (TSS) Response Rate at Week 24 | TSS response was defined as the percentage of participants who achieved at least 50% reduction in TSS over the 28 days immediately before the end of Week 24 compared with the 7 days immediately before the initiation of itacitinib immediate release (aseline).B | Analysis was not conducted because Part 2 never opened for enrollment. | Posted | Baseline; Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 2: Mean Change (From Day 1 Versus Week 12 and Week 24) in the 5 Multi-item Functional Scale Scores and the Multi-item Global Health Status Scale Score (EORTC QLQ-C30) | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was to be used to assess the improvement in quality of life. | Analysis was not conducted because Part 2 never opened for enrollment. | Posted | Baseline; Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of Participants Categorized as Improved on the Week 24 Patient Global Impression of Change (PGIC) | The PGIC consists of a single question pertaining to a participant's overall status since the start of the study. The questionnaire gives participants 7 options to describe their overall status including: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. | Analysis was not conducted because Part 2 never opened for enrollment. | Posted | Baseline; Week 24 |
|
|
up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Itacitinib 300 mg | itacitinib 300 mg | 2 | 4 | 3 | 4 | 4 | 4 |
| EG001 | Total | Total | 2 | 4 | 3 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Cytokine storm | Immune system disorders | MedDRA 26 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 26 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 26 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
|
The sponsor terminated study enrollment following an assessment regarding the expected duration of recruitment for the Phase 2 portion of the study combined with the availability of other study options for this patient population.
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | 1-855-463-3463 | 1-855-463-3463 | medinfo@incyte.com |
| Aug 20, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D011087 | Polycythemia Vera |
| D013922 | Thrombocytosis |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001791 | Blood Platelet Disorders |
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| ID | Term |
|---|---|
| C000718170 | itacitinib |
| C000603457 | INCB039110 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
| Participants |
|