NCT03600441

Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (estimated)
• Sponsor: Xynomic Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 × 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule.

Detailed description

Patients will be evaluated for objective response, Duration of Response (DOR), Progression Free Survival (PFS), Clinical Benefit Rate (CBR), Overall survival (OS), safety and tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and changes in health related quality of life. Patients may receive treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent. An independent data safety monitoring committee (iDMC) will evaluate the data pertaining to the futility and decide whether the study should stop or continue to the second stage. If the study continues to the second stage, a total of 139 patients will be studied.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Abexinostat	Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.

Timeline

• Start date: 2018-08-27
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2018-07-26
• Last updated: 2025-04-10

Locations

15 sites across 3 countries: United States, France, Spain

Regulatory

• FDA-regulated drug study