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Histone Deacetylase Inhibitor

Mocetinostat for Lymphoma

Phase 1 & 2

Waitlist Available

Led By Andrew Zelenetz, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study if mocetinostat can slow cancer progression in people with a CREBBP or EP300 mutation, as well as the potential side effects of the drug.

Eligible Conditions

Lymphoma
Non-Hodgkin's Lymphoma
Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Efficacy as Defined by Overall Response

Secondary outcome measures

Event Free Survival

Median Progression Free Survival/PFS

Number of Participants Evaluated for Toxicity According to the (NCI CTCAE) Version 4.0.

Side effects data

From 2016 Phase 2 trial • 20 Patients • NCT02303262

60%

Fatigue

40%

Anemia

40%

Neutrophil count decreased

40%

Nausea

30%

Anorexia

30%

Dyspnea

30%

Platelet count decreased

25%

Vomiting

20%

Insomnia

20%

Dysgeusia

20%

Diarrhea

20%

White blood cell decreased

15%

Constipation

10%

Dry mouth

10%

Acid reflux

10%

Alkaline phosphatase increased

10%

Headache

10%

Hypertension

10%

Pain

10%

Hypoalbuminemia

10%

Lymphocyte count decreased

10%

Fever

10%

Back pain

10%

Chills

10%

Decreased appetite

10%

Dehydration

10%

Dizziness

10%

Hypokalemia

Arthralgia

Pulmonary embolism

Peripheral sensory neuropathy

Syncope

Pharyngitis

Fungal infection

Hydronephrosis

Upper respiratory infection

Pruritic rash

Urinary tract infection

Achy

Alanine Aminotransferase increased

Muscle cramps

Right sided chest pain

Malaise

Dry skin

Ejection fraction decreased

Elevated LFTs

Erythematous neck rash

Fracture

Generalized muscle weakness

GGT increased

Laryngeal inflammation

Sciatic pain

Memory impairment

Neck pain

Sore nostril

Facial acne

Flatulence

Non-cardiac chest pain

Pericardial effusion

Pneumonia

Myalgia

Nasal irritation

Neck stiffness

Night sweats

Powerport soreness

Hypotension

Mucositis

QTCF elevated

Sharp left sided pain

Absolute neutrophil count decreased

Shoulder pain

Sore throat

Stomatitis

Throat irritation

Thrush

Neutropenia

Bronchopulmonary hemorrhage

Failure to thrive

Febrile neutropenia

Bruising

Burping

Calf tenderness/burning

Cord compression

Cough

Creatinine increased

Hypocalcemia

Hyponatremia

Hypophosphatemia

Thigh pain

Palpitations

Paresthesia

Pericardial tamponade

Pericarditis

Ventricular arrhythmia

Vertigo

Voice alteration

Weight loss

100%

80%

60%

40%

20%

Study treatment Arm

Mocetinostat and Gemcitabine

Trial Design

1Treatment groups

Experimental Treatment

Group I: MocetinostatExperimental Treatment1 Intervention

Patients who harbor mutations for CREBBP and/or EP300 will be started on mocetinostat 70 mg orally three times per week on a 28 day schedule in cycle 1. The dose will be escalated in cycle 2 to 90 mg orally three times per week on a 28 day schedule if there are no grade 3 or higher drug related toxicities. Therapy will continue until disease progression, intolerable toxicities or death.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mocetinostat

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MethylGene Inc.Industry Sponsor

2 Previous Clinical Trials

227 Total Patients Enrolled

1 Trials studying Lymphoma

7 Patients Enrolled for Lymphoma

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,848 Total Patients Enrolled

154 Trials studying Lymphoma

8,661 Patients Enrolled for Lymphoma

Andrew Zelenetz, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

4 Previous Clinical Trials

391 Total Patients Enrolled

3 Trials studying Lymphoma

161 Patients Enrolled for Lymphoma

Frequently Asked Questions

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

Could you provide a summary of the prior work conducted with Mocetinostat?

"Currently, there are 3 medical studies utilizing mocetinostat with none of them in the final phase. Most experiments related to this medication occur in New york City; however, other 5 sites have initiated trials as well."

Answered by AI

What is the approximate enrollment for this research project?

"Unfortunately, this research has already ceased accepting applicants. It was first posted on October 1st 2014 and last updated November 7th 2022. However, if you're looking for other studies of a similar nature, 1768 trials are currently recruiting participants with lymphoma while 3 clinical tests are hunting for patients taking part in Mocetinostat therapy."

Answered by AI

Are there further opportunities to join this investigation?

"This trial is not currently accepting candidates. Originally posted on October 1, 2014 and most recently updated on November 7th 2022, there are presently 1768 trials actively admitting participants with lymphoma and 3 studies for Mocetinostat recruiting patients."

Answered by AI

Is this research original and innovative?

"Research on Mocetinostat has been ongoing since 2014 when the first trial, sponsored by MethylGene Inc., commenced. After a successful Phase 1 & 2 approval following that initial study involving 7 participants, there are now 3 separate trials running in 4 cities across one nation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

2014. "Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02282358.