Spots Global Cancer Trial Database for Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis
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Trial Identification
Brief Title: Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis
Official Title: A Phase 1/2a Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Postpolycythemia Vera or Post-essential Thrombocythemia Myelofibrosis
Study ID: NCT04676529
Conditions
Interventions
Study Description
Brief Summary: This study will be an open-label phase 1/2a study to evaluate the safety and tolerability of PXS-5505 in patients with primary, postpolycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis.
Detailed Description: The study consists of three phases: a dose escalation phase, a cohort expansion phase, and an add-on phase. The dose escalation phase will follow a 3+3 design with a starting dose of 100 mg twice daily, and a treatment duration of 4 weeks. Patients will be able to participate in more than one dose level. During the cohort expansion phase, up to 24 patients will be treated at the dose determined appropriate based on safety, pharmacokinetic and pharmacodynamic results from the dose escalation phase, for a period of up to 6 months. Patients from the dose escalation phase will be able to participate in the cohort expansion phase. In the add-on phase PXS-5505 will be given to patients, already receiving a stable dose of ruxolitinib, for a period of 12 months. Up to 15 patients will enrol in the add-on phase in order to obtain 12 patients with at least 1 month's exposure to PXS-5505 on top of ruxolitinib. Note: The decision to include an add-on phase, where PXS-5505 is to be given on top of a stable ruxolitinib dose, was taken following a review of the data (safety, PK and PD) from the cohort expansion phase. There will be no washout period between dose escalation and dose expansion cohorts.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Comprehensive Cancer Center (UAB CCC), Birmingham, Alabama, United States
Novant Health Cancer Institute, Winston-Salem, North Carolina, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Liverpool Hospital, Liverpool, New South Wales, Australia
Ashford Cancer Centre Research, Adelaide, South Australia, Australia
St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
One Clinical Research, Perth, Western Australia, Australia
The Perth Blood Institute, West Perth, Western Australia, Australia
Inje University Busan Paik Hospital - Internal Medicine, Busan, Busan Gwang'yeogsi [Pusan-Kwan, Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], Korea, Republic of
Gachon University Gil Hospital, Incheon, Incheon Gwang'yeogsi [Inch'n-K, Korea, Republic of
National Cancer Center (Seoul Metro; northern), Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital - Bundang, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System- Haemat, Seoul, , Korea, Republic of
Asan Medical Centre, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Chang Gung Medical Foundation - ChiaYi Chang Gung Memorial Hospital - Hematology and Oncology, Chiayi City, Chiayi, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital - Internal Medicine - Taichung, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital - Hematology And Oncology, Taipei, , Taiwan
Contact Details
Name: Jana Baskar, MBBS MMedSc MBA
Affiliation: Syntara
Role: STUDY_DIRECTOR
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