A Study of Anagrelide Controlled Release (GALE-401) in Patients With High Platelet Counts Due to Bone Marrow Disorders

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
ThrombocytosisMyeloproliferative Neoplasms
Interventions
DRUG

Anagrelide CR

Starting dose of 0.5 mg b.i.d. (1.0 mg/day) titrated at weekly intervals, on an individual basis, to achieve the lowest dose required to achieve and maintain a target platelet count of 150 - 400 x 10e9/L, tolerability permitting. The dose will be increased at weekly intervals in steps not exceeding 0.5 mg/day; the rate of dose titration may be reduced (i.e., up to once every 2 weeks) at the discretion of the Investigator.

Trial Locations (11)

17325

Gettysburg Cancer Center, Hillsdale

27157

Wake Forest Baptist Health, Winston-Salem

33180

Innovative Medical Research of South Florida, Inc., Aventura

67214

Cancer Center of Kansas, Wichita

77030

The University of Texas MD Anderson Cancer Center, Houston

78130

Cancer Care Centers of South Texas, New Braunfels

78229

Cancer Care Centers of South Texas, San Antonio

91505

East Valley Hematology and Oncology Medical Group, Burbank

92024

California Cancer Associates for Research & Excellence (cCARE), Encinitas

92025

California Cancer Associates for Research & Excellence (cCARE), Escondido

93720

California Cancer Associates For Research and Excellence, Fresno

Sponsors
All Listed Sponsors
lead

Galena Biopharma, Inc.

INDUSTRY