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Clinical Trial 20600

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03886831

Phase: Phase I
Prinicipal Investigator: Andrew Kuykendall

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or 1-800-679-0775 Learn More
Overview

Study Title

A Phase I, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients with Advanced Solid Tumors and Hematologic Malignancies

Summary

This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with advanced cancers who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT543.

Objective

Primary: To describe any dose limiting toxicities (DLT) of PRT543, and to determine the maximally tolerated dose (MTD) and recommended phase II dose (RP2D) and schedule of PRT543, in patients with advanced solid tumors and certain hematologic malignancies Secondary: 1.To describe the adverse event profile and tolerability of PRT543 2.To describe the pharmacokinetic profile of PRT543 3.To describe any anti-tumor activity of PRT543 based on the measurement of objectiveresponses to PRT543 according to the RECIST 1.1 criteria for patients with solid tumorsand the disease-specific response criteria for patients with hematologic malignancies

Treatments

Therapies

Medications

Jakafi (Ruxolitinib); PRT543 (); Ruxolitinib ()

Inclusion Criteria

  • Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome; or relapsed myelofibrosis. All malignancies must be refractory to established therapies
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
  • Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use an effective method of contraception during the trial

  • Exclusion Criteria

  • Primary malignancies of the Central Nervous System(CNS) or uncontrolled CNS metastases
  • Requirement of pharmacologic doses of glucocorticoids
  • Prior treatment with chimeric antigen receptor T cells (CAR-T cells)
  • HIV positive; known active hepatitis B or C
  • Known hypersensitivity to any of the components of PRT543
  • Prior allogeneic bone marrow transplant; autologous hematopoietic transplantation less than 100 days since transplantation

  • 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.