NCT01217229

Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma

A Phase 2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary objective of this study is to evaluate the efficacy, as measured by overall response rate, of orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin lymphoma (HL). Secondary objectives include safety, the duration of response, the disease control rate, progression free survival, and how the drug affects your body.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	PLX3397	Capsules administered once or twice daily, continuous dosing. Subjects will begin with 900 mg/day, but should safety data allow in our PLX108-01 study, subject may dose at 1200 mg/day.

Timeline

• Start date: 2011-03-03
• Primary completion: 2012-04-26
• Completion: 2012-04-26
• First posted: 2010-10-08
• Last updated: 2020-06-30
• Results posted: 2013-03-15

Locations

6 sites across 1 country: United States