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LymphomaPhase 1/2NCT02282358

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

A Phase 1/2 study testing Mocetinostat in people with Lymphoma and Relapsed and Refractory, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to learn if the study drug mocetinostat can slow the progression of cancer in people who have a mutation in CREBBP or EP300 in the genetic makeup of their cancer. The potential side effects of mocetinostat will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mocetinostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
Oct 2014to 26 May 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has provided a signed study Informed Consent Form prior to performance of any study related procedurePatient is ≥ 18 years of age
  • Patient has histologically confirmed diagnosis of diffuse large B cell lymphoma or follicular lymphoma harboring mutations in CREBBP or EP300 with relapsed or refractory disease
  • Patients with diffuse large B cell lymphoma must have received at least two prior therapies and have received, declined or be ineligible for autologous or allogeneic stem cell transplant.
  • Patients with follicular lymphoma must have received at least two prior therapies.
  • Patients with either diffuse large B cell lymphoma or follicular lymphoma will be allowed to enroll after receiving only 1 prior therapy if they are felt to not be a candidate for further systemic chemotherapy.
  • Patient has at least one measurable lesion (≥ 2 cm) according to Cheson criteria [45]. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 - Patient has adequate bone marrow and organ function by:
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  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
  • Platelets ≥ 75 x 10^9/L (no platelet transfusion within past 14 days)
  • Hemoglobin (Hgb) ≥ 9.0 g/dL (no RBC transfusion within past 14 days)
  • International Normalized Ratio (INR) ≤ 1.5
  • Serum Creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 2.5 x ULN, or ≤ 5.0 x ULN for patients with documented hepatic involvement
  • Serum bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN for patients with Gilbert Syndrome or documented hepatic involvement.
  • Patients must have fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy (residual grade 1 toxicity, e.g. grade 1 peripheral neuropathy, and residual alopecia are allowed)

Who cannot join

  • Patient has received previous treatment with HDAC inhibitors
  • Patient has evidence of graft versus host disease (GVHD)
  • Patient has active or history of central nervous system (CNS) disease
  • Patient has impaired cardiac function including any of the following:
  • Presence or history of pericardial effusion (definitions are provided in and/or pericarditis.
  • Acute myocardial infarction, symptomatic angina pectoris ≤ 6 months prior to starting study drug
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  • Presence of congestive heart failure ≥ NYHA class 3
  • QTc > 480 ms on a screening ECG
  • Screening LVEF < 45% by echocardiography or MUGA
  • Uncontrolled cardiac arrhythmia including uncontrolled atrial fibrillation/atrial flutter/sinus tachycardia, complete left bundle branch block, congenital long QT syndrome
  • Presence of permanent cardiac pacemaker
  • Other clinically significant heart disease
  • Subject is taking warfarin at start of treatment or within 6 months prior to start of study treatment.
  • Patient has a concurrent malignancy or has a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or nonmelanomatous skin cancer)
  • Patient is concurrently using other approved or investigational antineoplastic agent
  • Patient has received chemotherapy, targeted anticancer therapy, pelvic and/or para-aortic radiotherapy or has had major surgery ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of mocetinostat (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patient is currently receiving increasing or chronic treatment (> 10 days) with corticosteroids or another immunosuppressive agent. The following uses of corticosteroids are permitted: single dose, topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
  • Patient has a history of non-compliance to medical regimen or inability to grant consent.
  • Concomitant medications causing prolonged QT which cannot be discontinued or changed to a different medication prior to initiating study
  • Patient is currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. Patients must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment.
  • Note: the oral anti-diabetic drugs troglitazone and pioglitazone are CYP3A inducers.
  • Patient has a known history of HIV (testing not mandatory), active Hepatitis B or C infection.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test (> 5 mIU/mL)
  • Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: An Open-Label Phase II Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

The purpose of this study is to learn if the study drug mocetinostat can slow the progression of cancer in people who have a mutation in CREBBP or EP300 in the genetic makeup of their cancer. The potential side effects of mocetinostat will also be studied.

Being tested
Mocetinostat
Keywords
Mocetinostat, 14-106
Medical subject headings
Lymphoma, Recurrence, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MocetinostatDrug

Study groups in NCT02282358
Study groupRoleWhat they receive
MocetinostatExperimentalPatients 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.
Receives: Drug: Mocetinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy as Defined by Overall Response

    as defined by overall response rate of Mocetinostat at one year in patients with relapsed/refractory DLBCL and FL who have inactivating mutations of acetyltransferase genes. Response will be measured according to the 2007 revised Cheson criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in sum of the product of the diameters (SPD) of up to 6 dominant lesions identified at baseline; Overall Response (OR) = CR + PR.

    Measured: 1 year

Secondary outcomes (3)

  1. Event Free Survival

    defined as time from the date of treatment start to the date of the first documented progressive disease (PD) or death due to any cause) rate using mocetinostat in this selected population will be estimated by the Kaplan-Meier method. Relapsed disease/progressive disease is defined as at least 50% increase of target measurable nodal lesions

    Measured: up to 17.8 months

  2. Median Progression Free Survival/PFS

    is defined as the time from the date of first occurrence of CR or PR whichever is recorded first to the date of the first objectively documented progressive disease (PD) or death due to any cause. The duration of response will be assessed based on the sub-cohort of patients who showed responses also using Kaplan-Meier.

    Measured: up to 17.8 months

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

    will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion26 May 2023
  4. Study completion26 May 2023

Why it stopped: Lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02282358
Sponsor's protocol ID
14-106
Status last verified
May 2023
First submitted
29 Oct 2014
Last updated
8 Mar 2024

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mocetinostat in people with Lymphoma and Relapsed and Refractory, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy as Defined by Overall Response (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02282358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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