A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate-2 or High-Risk Primary or Secondary Myelofibrosis

  • STATUS
    Recruiting
  • sponsor
    Sumitomo Dainippon
Updated on 18 June 2021

Summary

This is a Phase 1, multicenter, dose-escalation, open-label study to assess safety, tolerability, preliminary activity, pharmacokinetics and pharmacodynamics of TP-3654 in patients with intermediate-2 or high-risk myelofibrosis.

Description


Details
Condition Myelofibrosis
Clinical Study IdentifierTX275192
SponsorSumitomo Dainippon
Last Modified on18 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of primary myelofibrosis (PMF) or secondary myelofibrosis (post-PV MF / post-ET MF)
No longer respond to ruxolitinib or fedratinib or are ineligible to be treated with ruxolitinib or fedratinib
Grade ≥ 2 bone marrow fibrosis as confirmed by bone marrow biopsy
Enlarged Spleen
Experience at least 2 symptoms (fatigue, night sweat, itching, abdominal discomfort, pain under left rib, bone pain, or fullness after beginning to eat)
Platelet count ≥ 50K/uL
Adequate kidney and liver function
No spleen radiation within 6 months prior to screening
No splenectomy
No stem cell transplant at any time
Not eligible for stem cell transplant within 3 months (unless not willing to undergo transplantation OR a suitable donor not available are considered as transplant ineligible)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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