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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Male subjects with a female partner of childbearing potential must be vasectomized, or agree to use condoms as defined in Section 8.6.2, from first dose of tazemetostat until 3 months following the last dose of tazemetostat, or have a female partner who is NOT of childbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 24, 32, 56, and at end of study, an average of 2 years.
Awards & highlights
Study Summary
This trial is testing a new drug, tazemetostat, to see if it is effective in treating different types of solid tumors. There are 8 cohorts of subjects, each with a different type of tumor. The subjects will be given tazemetostat for 28 days, and then their response will be assessed. Treatment will continue until disease progression, unacceptable toxicity, or the subject withdraws from the study.
Who is the study for?
Adults over 18 with various advanced soft-tissue sarcomas, for which no standard treatments are available. Participants must have a life expectancy of more than 3 months and adequate organ function. They should not have had prior exposure to tazemetostat or similar drugs, major surgery within the last 3 weeks, or certain cardiovascular conditions.Check my eligibility
What is being tested?
The trial is testing Tazemetostat in combination with doxorubicin against doxorubicin plus placebo. Part 1 determines the safe dosage and side effects (tolerability) of Tazemetostat; Part 2 compares how long patients live without disease progression using these combinations.See study design
What are the potential side effects?
Possible side effects include reactions related to drug infusion, fatigue, digestive issues like nausea or vomiting, blood disorders such as anemia or clotting problems, liver and kidney function changes, heart complications including arrhythmias or heart failure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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I am a male and will use protection or have a partner who cannot become pregnant.
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I am 18 years old or older.
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My cancer has no standard treatment options left.
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My cancer has returned or didn't respond to treatment and can't be removed by surgery.
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All side effects from my previous cancer treatments are mild or stable.
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I have enough tumor samples for further testing.
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My blood, kidney, and liver tests are within normal ranges.
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There are no standard treatments available for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 24, 32, 56, and at end of study, an average of 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 24, 32, 56, and at end of study, an average of 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events (AEs) in Cohort 8
Objective response rate (ORR) in Cohorts 1,3,4,5,6 and 7
Percentage of Participants with Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
+1 moreSecondary outcome measures
Disease control rate (DCR) in Cohort 5, 6 and 8
Duration of response (DOR) in all Cohorts
Objective Response Rate (ORR) in Cohort 2
+2 moreSide effects data
From 2021 Phase 2 trial • 20 Patients • NCT0345672653%
Dysgeusia
41%
Nasopharyngitis
29%
Blood creatine phosphokinase increased
29%
Upper respiratory tract infection
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
24%
Rash
18%
Thrombocytopenia
18%
Blood creatinine increased
18%
Neutropenia
18%
Weight decreased
18%
Nausea
12%
Herpes simplex
12%
Influenza
12%
Urinary tract infection
12%
Amylase increased
12%
Pneumonia
12%
Malaise
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Gastric cancer
6%
Non-small cell lung cancer
6%
Abdominal pain
6%
Haematochezia
6%
Fatigue
6%
Oedema peripheral
6%
Blood pressure decreased
6%
Blood zinc decreased
6%
Gamma-glutamyltransferase increased
6%
Immature granulocyte count increased
6%
Hypertonic bladder
6%
Gastroenteritis
6%
Traumatic fracture
6%
Electrocardiogram QT prolonged
6%
Hypoalbuminaemia
6%
Aspartate aminotransferase increased
6%
Visual field defect
6%
Skin exfoliation
6%
Pneumocystis jirovecii pneumonia
6%
Nail disorder
6%
Rash maculo-papular
6%
Traumatic intracranial haemorrhage
6%
Tooth disorder
6%
Large intestine polyp
6%
Pyrexia
6%
Myalgia
6%
Haematuria
6%
Phlebitis
6%
Insomnia
6%
Bronchitis
6%
Upper respiratory tract inflammation
6%
Impetigo
6%
Hypogammaglobulinaemia
6%
Osteonecrosis of jaw
6%
Musculoskeletal chest pain
6%
Alanine aminotransferase increased
6%
Cataract
6%
Mechanical ileus
6%
Atypical pneumonia
6%
Periodontitis
6%
Pneumonia aspiration
6%
Leukopenia
6%
Pericardial effusion
6%
Conjunctival haemorrhage
6%
Visual impairment
6%
Epigastric discomfort
6%
Oral herpes
6%
Paronychia
6%
Fall
6%
Postoperative delirium
6%
Procedural pain
6%
Skin laceration
6%
Tooth fracture
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Hyperuricaemia
6%
Pain in extremity
6%
Tendon disorder
6%
Myelodysplastic syndrome
6%
Muscle spasticity
6%
Peripheral motor neuropathy
6%
Sciatica
6%
Syncope
6%
Asthma
6%
Dysphonia
6%
Erythema multiforme
6%
Keloid scar
100%
80%
60%
40%
20%
0%
Study treatment Arm
Participants With Follicular Lymphoma
Participants With Diffuse Large B-cell Lymphoma
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-label TazemetostatExperimental Treatment1 Intervention
All cohorts will receive 800 mg oral Tazemetostat twice a day in continuous 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,587 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
257 Previous Clinical Trials
54,878 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with tazemetostat or similar medications.I have not taken part in a drug trial within the last 30 days or 5 half-lives of the drug.I have not had major surgery in the last 3 weeks.My cancer has spread to my brain or its coverings.I've been cancer-free for 5 years or had non-melanoma skin cancer or in situ carcinoma treated successfully.You are allergic to tazemetostat or other drugs that work like it.I can take care of myself and am up and about more than half of my waking hours.Your biopsy results have been confirmed by a certified laboratory.You have a detectable tumor according to specific medical guidelines.Your heart function is within a certain range, and you have a certain level of activity tolerance.I am not pregnant, will use birth control, and my partner will use a condom or is vasectomized.I am a male and will use protection or have a partner who cannot become pregnant.I have severe blood cell issues or a history of bone marrow cancer.I have an active hepatitis B or C infection.I cannot take pills or have a condition that affects how my body absorbs them.I am a male and agree to use contraception during and for 3 months after the study.I have had a blood clot with symptoms in the last 2 weeks.I am currently being treated for an infection.I have a history of T-cell lymphoblastic lymphoma/leukemia.I am not taking any medications that are not allowed in the study.I am 18 years old or older.My cancer has no standard treatment options left.My cancer has worsened in the last 6 months.All side effects from my previous cancer treatments are mild or stable.I have enough tumor samples for further testing.My cancer has returned or didn't respond to treatment and can't be removed by surgery.My blood, kidney, and liver tests are within normal ranges.My seizures are under control with medication for at least 21 days.I don't have active brain bleeding or use blood thinners.Your immune system is weak, or you have a known history of HIV infection.You are expected to live for more than 3 months.I do not have serious heart problems or recent heart attacks or strokes.There are no standard treatments available for my condition.Your heart's QT interval, when adjusted for your heart rate, is less than or equal to 480 milliseconds.
Research Study Groups:
This trial has the following groups:- Group 1: Open-label Tazemetostat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Tumors Patient Testimony for trial: Trial Name: NCT02601950 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project have a large or small footprint in our state's hospitals?
"There are 8 locations currently participating in this study, which include Princess Margaret Hospital in Toronto, Mayo Clinic - Jacksonville in Jacksonville, and University of Colorado Denver in Aurora."
Answered by AI
What is the present regulatory standing of Tazemetostat?
"Tazemetostat falls into the category of a Phase 2 drug, so there is some evidence supporting its safety but not yet its efficacy. This was taken into consideration when score it a 2."
Answered by AI
Are people still being accepted into this experiment?
"Currently, this study is not looking for any more patients. The trial was first posted on December 22nd, 2015 and was last edited on May 9th, 2022. If you are interested in other studies, there are 3013 trials actively searching for patients with synovial sarcoma and 20 trials for Tazemetostat that are still enrolling participants."
Answered by AI
How many guinea pigs are part of this experiment?
"Presently, this study is not admitting any more participants. The initial posting was on December 22nd, 2015 and the most recent update was on May 9th, 2022. However, there are other trials underway that might be of interest; as of right now, there are 3013 clinical studies actively recruiting patients with synovial sarcoma and 20 for Tazemetostat."
Answered by AI
What distinguishes this research from other similar projects?
"Tazemetostat has completed 20 trials since 2015, with 8 of those trials having concluded. The drug is being tested in 21 different countries and 533 cities by Epizyme, Inc. Tazemetostat first went through a Phase 2 approval stage in 2015 with 250 participants."
Answered by AI
What is the precedence of Tazemetostat in clinical research?
"Tazemetostat was first researched in 2015 at the Sarcoma Center HELIOS Klinikum Berlin. 8 studies have completed since then, with 20 more presently active. Many of these newer investigations are based out of Toronto, Canada."
Answered by AI
Who else is applying?
What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I hope thus clinical trial help me.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Do I have to pay for the treatment?
How long will my treatment process take?
PatientReceived 2+ prior treatments
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