M19-753: Navitoclax w & w/o Ruxolitinib in MPN patients
Research type
Research Study
Full title
A Phase 1 Open-Label Study Evaluating the Safety and Tolerability, and Pharmacokinetics of Navitoclax Alone and in Combination with Ruxolitinib in Myeloproliferative Neoplasm Subjects
IRAS ID
288220
Contact name
Claire Harrison
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2020-002597-27
Duration of Study in the UK
8 years, 0 months, 1 days
Research summary
Myeloproliferative neoplasm (MPN) is a serious bone marrow cancer that causes blood cells in the bone marrow to produce too many blood cells or platelets. This leads to large scarring in the bone marrow, leading to severe anaemia, weakness, fatigue, and an enlarged spleen. Many people with MPN get progressively worse; some may develop a form of leukaemia (a type of blood cancer). The purpose of this study is to see how safe and effective navitoclax is, when given alone or in combination with ruxolitinib, for participants who have MPN.
Navitoclax (ABT-263) is an experimental drug being developed for the treatment of MPN. There are five parts to this study.
Parts 1a and 1b: Japanese participants with MPN uncontrollable with standard therapy
Part 2: Japanese and Taiwanese participants with primary or secondary post-polycythaemia vera MF (PPV-MF), post-essential thrombocytopenia MF (PET-MF), who have received ruxolitinib for at least 12 weeks prior to this study enrolment without getting suitable response.Parts 3 and 4: Global participants (USA and Europe) with MPN or chronic myelomonocytic leukemia (CMML) who have failed, are intolerant to, or refuse standard therapy.
Around 62 participants will be enrolled in approximately 30 sites.
Participants will take the following oral daily doses:
Part 1a, 1b, Part 3: navitoclax
Part 2: navitoclax and ruxolitinib combination therapy
Part 4: celecoxib (one dose each on Days 1 and 7), and navitoclax (once a day everyday starting Day 3)There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic if possible. If not possible a visit via phone call or video will be conducted. The effect of the treatment will be checked by medical assessments, imaging, blood tests, checking for side effects, and questionnaires.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0125
Date of REC Opinion
2 Dec 2021
REC opinion
Further Information Favourable Opinion