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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame up to 100 months

Awards & highlights

FORERUNNER Trial 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.Check my eligibility

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.See study design

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.

FORERUNNER Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I use reliable birth control methods.

Select...

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

FORERUNNER Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical effect of abexinostat

Secondary outcome measures

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

Clinical Benefit

Duration of response

+5 more

Side effects data

From undefined Phase 1 & 2 trial • 55 Patients • NCT00724984

57%

FATIGUE

50%

NAUSEA

50%

DIARRHOEA

50%

COUGH

36%

OEDEMA PERIPHERAL

36%

CHILLS

29%

THROMBOCYTOPENIA

29%

ANAEMIA

29%

SINUSITIS

29%

DYSPNOEA

21%

RASH

21%

CONSTIPATION

21%

VOMITING

21%

DECREASED APPETITE

21%

HEADACHE

21%

NEUTROPENIA

21%

DYSGEUSIA

14%

MUSCLE SPASMS

14%

ABDOMINAL PAIN

14%

FLATULENCE

14%

UPPER RESPIRATORY TRACT INFECTION

14%

BACK PAIN

14%

ARTHRALGIA

14%

DEHYDRATION

14%

HYPERGLYCAEMIA

14%

MUSCULAR WEAKNESS

14%

RHINORRHOEA

PRURITUS

PETECHIAE

PERIPHERAL SENSORY NEUROPATHY

CELLULITIS

HYPOMAGNESAEMIA

LEUKOPENIA

GROIN PAIN

FREQUENT BOWEL MOVEMENTS

EPISTAXIS

HYPOTENSION

HYPOGLYCAEMIA

LYMPH NODE PAIN

VISUAL ACUITY REDUCED

ABDOMINAL DISTENSION

ARTHROPATHY

DYSPEPSIA

ERUCTATION

GASTROOESOPHAGEAL REFLUX DISEASE

RECTAL HAEMORRHAGE

STOMATITIS

CHEST DISCOMFORT

CHEST PAIN

EARLY SATIETY

INFLUENZA LIKE ILLNESS

LOCALISED OEDEMA

PERFORMANCE STATUS DECREASED

PYREXIA

CANDIDIASIS

INFECTED BITES

NASOPHARYNGITIS

OTITIS MEDIA

PNEUMONIA

TOOTH INFECTION

URINARY TRACT INFECTION

ARTHROPOD BITE

ASPARTATE AMINOTRANSFERASE INCREASED

BLOOD LACTATE DEHYDROGENASE INCREASED

HAEMOGLOBIN

WEIGHT DECREASED

WEIGHT INCREASED

HYPERKALAEMIA

HYPERNATRAEMIA

HYPOPHOSPHATAEMIA

INCREASED APPETITE

MUSCULOSKELETAL PAIN

MYALGIA

PAIN IN EXTREMITY

AREFLEXIA

ATAXIA

INTENTION TREMOR

LOSS OF CONSCIOUSNESS

MEMORY IMPAIRMENT

MOTOR DYSFUNCTION

NEUROPATHY PERIPHERAL

ANXIETY

INSOMNIA

MICTURITION URGENCY

NOCTURIA

URINARY INCONTINENCE

DYSPNOEA EXERTIONAL

HICCUPS

NASAL CONGESTION

OROPHARYNGEAL PAIN

PULMONARY CONGESTION

RALES

ALOPECIA

DRY SKIN

HYPERHIDROSIS

TROPONIN INCREASED

BLOOD CREATININE INCREASED

SPINAL COLUMN STENOSIS

JUGULAR VEIN THROMBOSIS

HAEMORRHOIDAL HAEMORRHAGE

ATRIAL FIBRILLATION

MELAENA

LYMPHOPENIA

SINUS TACHYCARDIA

ABDOMINAL PAIN UPPER

APHTHOUS STOMATITIS

HYPERBILIRUBINAEMIA

HYPERURICAEMIA

ALLERGY TO ARTHROPOD BITE

HYPOALBUMINAEMIA

HYPOCALCAEMIA

HYPOKALAEMIA

FLUSHING

CLUBBING

NECK PAIN

DIZZINESS

TENSION HEADACHE

PLATELET COUNT DECREASED

DRY EYE

100%

80%

60%

40%

20%

Study treatment Arm

Mantle Cell Lymphoma/Phase II

Cohort 1(30 mg/m2, 5days/wk)/Phase I

Cohort 2(45 mg/m2, 5days/wk)/Phase I

Cohort 3(45 mg/m2, 7days/wk)/Phase I

Cohort 4(60 mg/m2,7days/wk)/Phase I

Follicular/Phase II

FORERUNNER 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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Xynomic Pharmaceuticals, Inc.Lead Sponsor

10 Previous Clinical Trials

1,070 Total Patients Enrolled

Connie W Batlevi, MD,PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Abexinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03600441 — Phase 2

Follicular Lymphoma Research Study Groups: Abexinostat

Follicular Lymphoma Clinical Trial 2023: Abexinostat Highlights & Side Effects. Trial Name: NCT03600441 — Phase 2

Abexinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03600441 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are able to join this clinical research initiative?

"Unfortunately, this trial has concluded its search for participants. The original posting date of the study was August 27th 2018, and the most recent update was on August 18th 2022. If you are looking to join another clinical trial related to lymphoma or follicular diseases involving Abexinostat treatment, there are currently 1719 studies actively enrolling patients that may be suitable options."

Answered by AI

Are there still slots available for prospective participants in this trial?

"Unfortunately, this experiment has temporarily suspended its recruitment process; the initial post was on August 27th 2018 and an update most recently occurred on August 18th 2022. Nonetheless, there are numerous other clinical trials open for enrollment that involve lymphoma, follicular or Abexinostat - 1719 of them in total."

Answered by AI

Are there any US-based facilities currently investigating this trial?

"This research project is currently admitting patients at Arlington Cancer Center in Texas, Advocate Medical Group - Park Ridge and Luther Lane - Oncology situated in Illinois as well as Central Texas Veterans Health Care System - NAVREF located in New york. Additionally, six other sites are available for enrollment."

Answered by AI

Is Abexinostat associated with any potentially perilous outcomes?

"Abexinostat's safety is rated a 2, as there has been limited prior evidence of efficacy but some data suggesting its security."

Answered by AI

Can you inform me of other investigations that have employed Abexinostat?

"Currently, 8 clinical trials assessing the efficacy of Abexinostat are being conducted. One of which is in its terminal phase 3 stage. 117 different medical institutions situated around Krakow, Texas are participating in these experiments."

Answered by AI

Does this trial represent a pioneering research effort?

"Research into Abexinostat began in 2012 when it was sponsored by Pharmacyclics LLC. After a successful Phase 1 clinical trial involving 120 participants, the medication received approval and is currently being studied across 7 nations with 8 active trials located within 27 cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

2018. "Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03600441.

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