Evaluation of Ruxolitinib in Combination With PU-H71 for Treatment of Myelofibrosis

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Samus Therapeutics, Inc.
Study ID
NCT03373877
Phase
PHASE1
Status
Terminated

Conditions

  • Myelofibrosis
  • Post-essential Thrombocythemia Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PU-H71 — DRUG
    PU-H71 treatments will be administered by IV infusion on days 1, 8, and 15 of each 28-day cycle.
  • Ruxolitinib — DRUG
    Dosing will be in accordance with current package insert and dose subject was on during study entry.

Study Details

This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine Maximum Tolerated Dose (MTD). The second part of the study (Dose Confirmation) will confirm the recommended Phase 2 dose (RP2D) in an expanded population.

Key Dates

First listed
Dec 14, 2017
Start date
May 24, 2018
Status verified
Nov 2022
Primary completion
Oct 17, 2019
Completion
Mar 10, 2020

Study Design

Enrollment
4 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose 1: PU-H71 225 mg/m2 + ruxolitinib
    Cohort 1
  • Experimental: Dose 2: PU-H71 300 mg/m2 + ruxolitinib
    Cohort 2
  • Experimental: Dose 3: PU-H71 400 mg/m2 + ruxolitinib
    Cohort 3
  • Experimental: Dose 4: PU-H71 600 mg/m2 + ruxolitinib
    Cohort 4

Primary Outcome Measure

Incidence of adverse events [ Time Frame: 12 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06511-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
University of MichiganAnn ArborMichigan48109-
Karmanos Cancer InstituteDetroitMichigan48201-
University of Nebraska Medical CenterOmahaNebraska68198-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland Clinic - Taussig Cancer InstituteClevelandOhio44195-
Abramson Cancer Center - University of PennsylvaniaPhiladelphiaPennsylvania19104-
MD Anderson Cancer CenterHoustonTexas77030-
Mays Cancer Center UT Health San AntonioSan AntonioTexas78229-3900-

Find similar trials in New Haven, CT

By research site
Yale Cancer Center· New Haven, CTOchsner Clinic Foundation· New Orleans, LAUniversity of Michigan· Ann Arbor, MIKarmanos Cancer Institute· Detroit, MIUniversity of Nebraska Medical Center· Omaha, NEDuke University Medical Center· Durham, NC

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