Phase 1/2 Study With an Open-label Dose Escalation Phase Followed by a Randomized, Double-blind Phase of SLN124 in Patients With Polycythemia Vera
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is a Phase 1/2, multicenter study with an open-label dose escalation followed by a randomized placebo controlled and double-blind phase of SLN124 in adult patients with Polycythemia Vera (PV) to assess the safety, tolerability, efficacy, pharmacokinetic (PK), and Pharmacodynamic (PD) response of SLN124.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male and female patients aged 18 years or older.
• A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria:
• Suitable phlebotomy history
• Must agree to adhere to appropriate contraception requirements
• Patients who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before dosing and have recovered from any adverse events due to cytoreductive therapy.
• Patients receiving cytoreductive therapy with hydroxyurea, interferon, busulfan or ruxolitinib must have received a stable dose of cytoreductive therapy for at least 12 weeks before dosing and with no planned change in dose.
• Patients must have had a dermatological examination within 6 months prior to screening.
• Must have an Eastern Cooperative Oncology Group score of 0, 1, or 2.
Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
North Carolina
Duke Cancer Institute
NOT_YET_RECRUITING
Durham
New York
Mount Sinai Hospital
RECRUITING
New York
Texas
North Houston Cancer Clinics
COMPLETED
Huntsville
Renovatio Clinical
RECRUITING
The Woodlands
Other Locations
Australia
Pindara Private Hospital
RECRUITING
Benowa
Ashford Cancer Centre Research
RECRUITING
Kurralta Park
Alfred Health
RECRUITING
Melbourne
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Linear Clinical Research
RECRUITING
Nedlands
Epworth HealthCare
RECRUITING
Richmond
Bulgaria
MHAT Dr Nikola Vasiliev AD
RECRUITING
Kyustendil
Medical Centre Leo Clinic EOOD
RECRUITING
Plovdiv
Malaysia
Hospital Ampang
RECRUITING
Ampang
Hospital Sultanah Aminah
RECRUITING
Johor Bahru
Hospital Sultanah Nur Zahirah
RECRUITING
Kuala Terengganu
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
Hospital Umum Sarawak
RECRUITING
Kuching
Poland
Uniwersyteckie Centrum Klinlczne
RECRUITING
Gdansk
PRATIA Hematologia Sp. z o. o.
RECRUITING
Katowice
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie