A study evaluating the impact of Itacitinib alone or when added to ruxolitinib for the treatment of myelofibrosis

Phase 1

• Conditions: Myelofibrosis; MedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10074689Term: Post polycythemia vera myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10074690Term: Post essential thrombocythemia myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10074691Term: Post polycythaemia vera myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10074692Term: Post essential thrombocythaemia myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10077161Term: Primary myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-005109-11-AT
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-28
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Cohort A only
• Receiving ruxolitinib dose of less than 20 mg daily with no dose increase or no dose modification in the last 8 weeks before screening visit.
Cohort B only
• Must have had initial reduction in spleen on ruxolitinib treatment (response is defined by any spleen length or volume reduction, by palpation or MRI/CT assessment, from baseline while on previous ruxolitinib treatment per IWG-MRT ELN 2013 guidelines):
- Followed by documented evidence of progression in spleen length or volume OR
- Discontinued ruxolitinib for hematologic toxicities, after the initial reduction in spleen length or volume.
All subjects
• Men and women, aged 18 years or older.
• Confirmed diagnosis of PMF, PPV-MF, or PET-MF according to revised WHO 2016 criteria.
• Must have palpable spleen of = 5 cm below the left subcostal margin on physical examination at the screening visit. (If spleen is not palpable due to body habitus, spleen enlargement must be documented by other means [eg, ultrasound or MRI] and study sponsor medical monitor be contacted for acceptance).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

All subjects
• Lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better.
• Previous treatment with itacitinib or JAK1 inhibitors (JAK1/JAK2 inhibitor ruxolitinib is permitted).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified