TGR-1202 + Ruxolitinib PMF PPV-MF PET-MF MDS/MPN Polycythemia Vera Resistant to Hydroxyurea

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT02493530
Phase
PHASE1
Status
Completed

Conditions

  • Myelofibrosis
  • Polycythemia Vera

Eligibility Criteria

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

Interventions

  • TGR-1202 — DRUG
    Stage 1 will include myelofibrosis or hydroxyurea-resistant/refractory PV patients already taking therapeutic levels of ruxolitinib, but who are not achieving maximal response at highest tolerated dose of ruxolitinib. Stage 2 will include myelofibrosis or hydroxyurea-resistant/refractory PV patients who have never been on JAK-STAT inhibitory agents, and includes simultaneously initiation of both ruxolitinib and TGR-1202. TGR-1202 will be administered at or below the recommended dose established in Stage 1. Expansion will commence after proper combination doses of both agents is established.
  • ruxolitinib — DRUG

Study Details

This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered together with ruxolitinib in patients with myeloproliferative neoplasms (specifically: polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.

Key Dates

Start date
Jul 31, 2015
Status verified
Aug 2025
Primary completion
Mar 21, 2023
Completion
May 31, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Escalation and expansion
    TGR1202 and Ruxolitinib combination

Primary Outcome Measure

Safety of TGR1202 in combination with ruxolitinib [ Time Frame: </=12 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic - ArizonaPhoenixArizona85054-
University of Colorado Cancer CenterAuroraColorado80045-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Mays Cancer Center at University of Texas Health San AntonioSan AntonioTexas78229-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic - Arizona· Phoenix, AZUniversity of Colorado Cancer Center· Aurora, COVanderbilt-Ingram Cancer Center· Nashville, TNMays Cancer Center at University of Texas Health San Antonio· San Antonio, TXMedical College of Wisconsin· Milwaukee, WI

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