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Mocetinostat + Vinorelbine for Rhabdomyosarcoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 20 Patients • NCT02303262Trial Design
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Who is running the clinical trial?
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- I am not pregnant, breastfeeding, or planning to become pregnant and agree to use two forms of birth control during the study.My platelet count is above 100,000 and I haven't had a transfusion in the last week.My rhabdomyosarcoma is advanced, cannot be surgically removed, or has returned, and standard treatments have failed.I am 17 or older and can do most daily activities, or I am under 16 and mostly active.My heart's electrical cycle (QTc interval) is longer than usual.I had cancer before, but it wasn't skin cancer or a completely removed in situ carcinoma in the last 3 years.I am a male and will avoid fathering a child during and 90 days after the trial.I've had cancer treatments before and tolerated them well, with enough recovery time.I have not fully recovered from recent surgery, except for procedures to place a central venous catheter or port.I am over 18 years old for the first group, or over 12 for later groups.My liver function tests are within the required range.I am willing and able to follow the study's schedule and procedures.I haven't had heart issues, strokes, clots, or needed heart rhythm drugs in the last 6 months.I do not have any active infections, including hepatitis and HIV.My brain involvement is stable without needing seizure medication, and if I'm on steroids, it's a low stable dose.My kidney function, measured by creatinine levels, is within the normal range.All side effects from my previous cancer treatments, except for hair loss, have mostly gone away.My hemoglobin level is above 9.0 g/dL, transfusions included.I have risk factors for a specific heart rhythm issue (like heart failure or family history of long QT syndrome).I can sign, or if under 18, my guardian can sign the consent form approved by the ethics committee.I've had radiotherapy but followed the required waiting periods before joining this trial.You are expected to live for at least three more months.I have brain metastases that are causing symptoms.I am not taking medication that affects my heart's rhythm.I am currently breastfeeding.
- Group 1: Treatment (vinorelbine, mocetinostat)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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