EUCTR2017-005109-11-NL
Active, not recruiting
Phase 1
An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis
ConditionsMyelofibrosisMedDRA 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myelofibrosis
- Sponsor
- Incyte Corporation
- Enrollment
- 42
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
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).
Outcomes
Primary Outcomes
Not specified
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