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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

March 21, 2023

Study Completion Date

May 31, 2024

Conditions
MyelofibrosisPolycythemia Vera
Interventions
DRUG

TGR-1202

"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."

DRUG

ruxolitinib

Trial Locations (5)

37232

Vanderbilt-Ingram Cancer Center, Nashville

53226

Medical College of Wisconsin, Milwaukee

78229

Mays Cancer Center at University of Texas Health San Antonio, San Antonio

80045

University of Colorado Cancer Center, Aurora

85054

Mayo Clinic - Arizona, Phoenix

All Listed Sponsors
lead

Vanderbilt-Ingram Cancer Center

OTHER

NCT02493530 - TGR-1202 + Ruxolitinib PMF PPV-MF PET-MF MDS/MPN Polycythemia Vera Resistant to Hydroxyurea | Biotech Hunter | Biotech Hunter