Study to Evaluate Activity of 2 DoseLevels of Imetelstat in Subjects with Intermediate-2 or High-Risk Myelofibrosis (MF)previously treated with Janus Kinase (JAK) Inhibitor

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Myelofibrosis (MF) is classified as a myeloproliferative neoplasm (MPN); MedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2015-000946-41-IT
• Lead Sponsor: JANSSEN CILAG INTERNATIONAL NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-06
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- Diagnosis of PMF according to the revised WHO criteria; or PET-MF or PPV-MF according to the IWG-MRT criteria
- DIPSS intermediate-2 or high risk MF
- Measurable splenomegaly prior to study entry as demonstrated by
palpable spleen measuring greater than or equal to (>=) 5 cm below the
left costal margin OR spleen volume of >= 450 cm^3 measured by MRI

- Active symptoms of MF as demonstrated by a symptom score of at least5 points (on a 0 to 10 scale) on at least one of the symptoms or a score
of 3 or greater on at least 2 of the symptoms
- Documented progressive disease during or after JAK inhibitor therapy

- ECOG performance status 0, 1 or 2

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

Peripheral blood blast count of >= 10% or bone marrow blast count of
>=10%
- Prior treatment with imetelstat
- Major surgery within 4 weeks of randomization
- Past or present active hepatitis infection of any type or known acute or
chronic liver disease including cirrhosis
- Prior history of hematopoietic stem cell transplant

Study & Design

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