CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
PLX3397drug
Likely dose
PLX3397 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01217229
NCT01217229Phase 2Completed
CompareCT.gov

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

Daiichi Sankyo·interventional·Posted Oct 8, 2010·Updated Jun 30, 2020

In Brief

A Phase 2 clinical trial evaluating PLX3397 for Hodgkin Lymphoma. Completed, enrolled 20 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHodgkin Lymphoma
CountriesUnited States
CollaboratorsPlexxikon

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2010
Enrollment StartMar 3, 2011
Primary CompletionApr 26, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.7 years ago

Interventions

PLX3397drug

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.