Moffitt Cancer Center: Clinical Trial 20102

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Clinical Trial 20102

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04057040

Phase: Phase II
Prinicipal Investigator: Andrew Kuykendall

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients with Phlebotomy-Requiring Polycythemia Vera

Summary

This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycythemia vera.

Objective

1. Obtain a preliminary estimate of PTG-300s efficacy in phlebotomy-requiring polycythemia vera (PCV) subjects including changes in phlebotomy requirement and splenomegaly. 2. Assess the safety of PTG-300 in PCV subjects who are phlebotomy requiring.

Treatments

Therapies

Medications

PTG-300 (); Placebo ()

Inclusion Criteria

All participants must meet ALL of the following inclusion criteria

18 years or older

Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera (PV)

Hematocrit 40%-45% before dosing

Phlebotomy requiring defined as: Regularly spaced phlebotomies over at least 24 weeks prior to Screening, at least 3 phlebotomies during the 24 weeks prior to Screening, Last phlebotomy within 8 weeks before Screening

Records of all phlebotomies performed for at least 24 weeks (preferably up to 52 weeks) before Screening are available

Participants who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events due to cytoreductive therapy

Subjects receiving cytoreductive therapy with hydroxyurea, interferon, or ruxolitinib must have received cytoreductive therapy for at least 24 weeks and be on a stable dose for at least 8 weeks before screening with no planned change in dose

Exclusion Criteria

Participants must meet NONE of the following exclusion criteria

Active or chronic bleeding within 4 weeks of screening

Meets the criteria for post-PCV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)

Known primary or secondary immunodeficiency

Any surgical procedure requiring general anesthesia within 1 month prior to screening or planned elective surgery during the study

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.