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Histone Deacetylase Inhibitor

Mocetinostat + Vinorelbine for Rhabdomyosarcoma

Phase 1
Recruiting
Led By Noah C. Federman, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Platelets (PLT) >= 100,000/mm^3 (>= 100 x 10^9/L) (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to screening)
Have histologically or cytological confirmed diagnosis of rhabdomyosarcoma with locally advanced/unresectable, metastatic, refractory or relapsed disease who have failed standard therapy and for whom no known curative therapy exists
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of mocetinostat when given with vinorelbine to treat kids, teens, and young adults with rhabdomyosarcoma that has spread and is not responding to treatment or has come back.

Who is the study for?
This trial is for children, adolescents, and young adults with rhabdomyosarcoma that's advanced or returned after treatment. Participants need to have a certain level of hemoglobin, be able to follow the study plan, and give informed consent (with guardian consent if under 18). They should not be pregnant or breastfeeding and must agree to contraception measures.Check my eligibility
What is being tested?
The trial tests mocetinostat combined with vinorelbine in treating rhabdomyosarcoma. Mocetinostat may block enzymes needed for tumor growth while vinorelbine could stop cell division. The goal is to see if this combination works better than vinorelbine alone.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, low blood counts increasing infection risk, liver issues, heart problems like changes in heartbeat rhythm or function. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My platelet count is above 100,000 and I haven't had a transfusion in the last week.
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My rhabdomyosarcoma is advanced, cannot be surgically removed, or has returned, and standard treatments have failed.
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I am 17 or older and can do most daily activities, or I am under 16 and mostly active.
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I am over 18 years old for the first group, or over 12 for later groups.
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My liver function tests are within the required range.
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My kidney function, measured by creatinine levels, is within the normal range.
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All side effects from my previous cancer treatments, except for hair loss, have mostly gone away.
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My hemoglobin level is above 9.0 g/dL, transfusions included.

Timeline

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
To describe any dose-limiting toxicity (DLT)
To determine the maximum tolerated dose (MTD) or highest protocol defined doses (in the absence of exceeding the MTD)
Secondary outcome measures
Area under the Plasma Concentration versus Time Curve (AUC) of mocetinostat
Clearance (CL) of mocetinostat
Disease Control (DC)
+7 more

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%
Acid reflux
10%
Alkaline phosphatase increased
10%
Dry mouth
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
5%
Peripheral sensory neuropathy
5%
Pharyngitis
5%
Pulmonary embolism
5%
Fungal infection
5%
Hydronephrosis
5%
Upper respiratory infection
5%
Syncope
5%
Pruritic rash
5%
Urinary tract infection
5%
Achy
5%
Alanine Aminotransferase increased
5%
Arthralgia
5%
Muscle cramps
5%
Right sided chest pain
5%
Malaise
5%
Dry skin
5%
Ejection fraction decreased
5%
Elevated LFTs
5%
Erythematous neck rash
5%
Fracture
5%
Generalized muscle weakness
5%
GGT increased
5%
Laryngeal inflammation
5%
Sciatic pain
5%
Memory impairment
5%
Neck pain
5%
Sore nostril
5%
Facial acne
5%
Flatulence
5%
Non-cardiac chest pain
5%
Pericardial effusion
5%
Pneumonia
5%
Myalgia
5%
Nasal irritation
5%
Neck stiffness
5%
Night sweats
5%
Powerport soreness
5%
Hypotension
5%
Mucositis
5%
QTCF elevated
5%
Sharp left sided pain
5%
Absolute neutrophil count decreased
5%
Shoulder pain
5%
Sore throat
5%
Stomatitis
5%
Throat irritation
5%
Thrush
5%
Neutropenia
5%
Bronchopulmonary hemorrhage
5%
Failure to thrive
5%
Febrile neutropenia
5%
Bruising
5%
Burping
5%
Calf tenderness/burning
5%
Cord compression
5%
Cough
5%
Creatinine increased
5%
Hypocalcemia
5%
Hyponatremia
5%
Hypophosphatemia
5%
Thigh pain
5%
Palpitations
5%
Paresthesia
5%
Pericardial tamponade
5%
Pericarditis
5%
Ventricular arrhythmia
5%
Vertigo
5%
Voice alteration
5%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mocetinostat and Gemcitabine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (vinorelbine, mocetinostat)Experimental Treatment2 Interventions
Participants receive mocetinostat in combination with vinorelbine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mocetinostat
2016
Completed Phase 2
~270
Vinorelbine
2013
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,038 Total Patients Enrolled
1 Trials studying Rhabdomyosarcoma
14 Patients Enrolled for Rhabdomyosarcoma
Mirati Therapeutics Inc.Industry Sponsor
69 Previous Clinical Trials
7,947 Total Patients Enrolled
Phase One FoundationOTHER
3 Previous Clinical Trials
145 Total Patients Enrolled

Media Library

Mocetinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04299113 — Phase 1
Rhabdomyosarcoma Research Study Groups: Treatment (vinorelbine, mocetinostat)
Rhabdomyosarcoma Clinical Trial 2023: Mocetinostat Highlights & Side Effects. Trial Name: NCT04299113 — Phase 1
Mocetinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04299113 — Phase 1

Frequently Asked Questions

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

Is the registration period still open for this clinical trial?

"According to clinicaltrials.gov, this medical trial is currently open for participants; it was first posted on the 14th of May 2020 and its information most recently updated on May 13th 2022."

Answered by AI

Is Mocetinostat a secure medication for individuals?

"Since this is an early-stage trial, the safety rating for Mocetinostat was assigned a score of 1 due to its limited evidence regarding efficacy and protection."

Answered by AI

What key outcomes is the research team hoping to achieve?

"This endeavour, which will be charted out over a 12-month period, aims to identify the Maximum Tolerated Dose (MTD) or uppermost protocol defined dosage. Secondary objectives involve assessing Adverse Events with the NCI CTCAE (Version 4.03), measuring Mocetinostat's Half-Life [T1/2], and calculating Clearance (CL). Descriptive statistics such as means, standard deviations, medians, minimums and maximums are also expected from these analyses."

Answered by AI

In which medical scenarios is the drug Mocetinostat typically implemented?

"Mocetinostat is a common treatment for untreated conditions, as well as monotherapy, sarcomas of the soft tissue (STS), and cervical cancer that has recurred."

Answered by AI

How many participants are included in this clinical investigation?

"That is correct. Information found on clinicaltrials.gov states that this medical study, opened on May 14th 2020, is presently recruiting patients. 38 participants are needed from 1 research centre."

Answered by AI

Has the efficacy of Mocetinostat been tested in prior research endeavors?

"At this time, there are 62 different ongoing clinical trials for mocetinostat with 21 of those studies in Phase 3. Of these investigations, 3435 sites throughout Shanghai are running the experiments."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
UCLA / Jonsson Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby May 2024