Abexinostat for Follicular Lymphoma
(FORERUNNER Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen byConnie Batlevi, MD, PhD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Xynomic Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with Grade 1, 2, or 3a follicular lymphoma that's come back or didn't respond to at least three prior treatments. Participants must use effective birth control and not breastfeed or donate sperm during the study and for 90 days after. Exclusions include central nervous system lymphoma history, previous abexinostat treatment, cardiac issues, recent investigational drugs, other cancers within three years (except skin cancer), Grade 3b lymphoma or large B-cell transformation.

Inclusion Criteria

I am a woman who cannot become pregnant because I am postmenopausal or have been surgically sterilized.

My lymphoma is confirmed as Grade 1, 2, or 3a.

I agree not to donate sperm from the start of the study until 90 days after the last dose.

+5 more

Exclusion Criteria

Has received any investigational medication within 30 days or 5 half-lives prior to Day 1, whichever is longer

I have been cancer-free from other types of cancer for over 3 years.

I have a heart condition.

+4 more

Participant Groups

The trial tests Abexinostat in patients with relapsed/refractory follicular lymphoma following multiple therapies. Patients will take Abexinostat orally twice daily on a schedule of one week on followed by one week off.

1Treatment groups

Experimental Treatment

Group I: AbexinostatExperimental Treatment1 Intervention

Abexinostat tablets will be administered orally at 80 mg (4 × 20 mg tablets) BID (twice a day) 4 hours apart for 7 days in a "one week on, one week off" schedule (on Days 1 to 7 and Days 15 to 21 of each 28-day cycle).