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Histone Deacetylase Inhibitor

Abexinostat for Follicular Lymphoma (FORERUNNER Trial)

Phase 2

Waitlist Available

Led By Connie W Batlevi, MD,PhD

Research Sponsored by Xynomic Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients must be of non-childbearing potential, defined as postmenopausal (≥ 1 year without any menses) prior to Screening, or documented surgically sterile (≥ 1 month prior to Screening)

Has histologically confirmed Grade 1, 2, or 3a follicular lymphoma

Must not have

Has any types of cardiac impairment at the time of enrollment

Has diagnosis of Grade 3b follicular lymphoma, or transformation to diffuse large B-cell lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame up to 100 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for people with a certain type of cancer who have had three or more types of treatment already. The drug is given two days in a row, then the patient rests for a week, and the cycle repeats.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Abexinostat may include gastrointestinal symptoms like nausea and diarrhea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver function abnormalities and potential heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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My follicular lymphoma has worsened or not responded to the last treatment, and I have a tumor ≥ 3 cm.

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I use reliable birth control methods.

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I agree not to breastfeed during and for 90 days after the study ends.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart condition.

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I have been diagnosed with a severe type of lymphoma.

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I had a stem cell transplant from a donor within the last 6 months or from myself within the last 3 months.

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I have had lymphoma in my brain or spinal cord.

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I have been treated with abexinostat before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame up to 100 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame up to 100 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame up to 100 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical effect of abexinostat

Secondary study objectives

Change in the interval corrected for heart rate (QTc) interval

Clinical Benefit

Duration of response

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abexinostat

Not yet FDA approved

0 / 11Eligibility criteria met