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EZH2 Inhibitor
Tazemetostat for Sarcoma
Phase 2
Waitlist Available
Research Sponsored by Epizyme, Inc.
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
Must not have
Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2 (EZH2)
Has participated in another interventional clinical study and received investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the planned first dose of tazemetostat
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 24, 32, 56, and at end of study, an average of 2 years.
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously been treated with tazemetostat or similar medications.
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I have not taken part in a drug trial within the last 30 days or 5 half-lives of the drug.
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I have not had major surgery in the last 3 weeks.
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My cancer has spread to my brain or its coverings.
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I cannot take pills or have a condition that affects how my body absorbs them.
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I have severe blood cell issues or a history of bone marrow cancer.
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I have a history of T-cell lymphoblastic lymphoma/leukemia.
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I am not taking any medications that are not allowed in the study.
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I am currently being treated for an infection.
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I have an active hepatitis B or C infection.
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I have had a blood clot with symptoms in the last 2 weeks.
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I do not have serious heart problems or recent heart attacks or strokes.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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%
Upper respiratory tract infection
29%
Blood creatine phosphokinase increased
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
24%
Rash
18%
Weight decreased
18%
Blood creatinine increased
18%
Thrombocytopenia
18%
Neutropenia
18%
Nausea
12%
Influenza
12%
Amylase increased
12%
Herpes simplex
12%
Malaise
12%
Pneumonia
12%
Urinary tract infection
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Phlebitis
6%
Visual field defect
6%
Aspartate aminotransferase increased
6%
Blood zinc decreased
6%
Haematuria
6%
Electrocardiogram QT prolonged
6%
Skin exfoliation
6%
Oedema peripheral
6%
Gastroenteritis
6%
Impetigo
6%
Hypogammaglobulinaemia
6%
Osteonecrosis of jaw
6%
Rash maculo-papular
6%
Nail disorder
6%
Pyrexia
6%
Myalgia
6%
Gamma-glutamyltransferase increased
6%
Insomnia
6%
Hypertonic bladder
6%
Fatigue
6%
Traumatic intracranial haemorrhage
6%
Traumatic fracture
6%
Upper respiratory tract inflammation
6%
Blood pressure decreased
6%
Hypoalbuminaemia
6%
Musculoskeletal chest pain
6%
Gastric cancer
6%
Non-small cell lung cancer
6%
Haematochezia
6%
Tooth disorder
6%
Bronchitis
6%
Abdominal pain
6%
Large intestine polyp
6%
Pneumocystis jirovecii pneumonia
6%
Alanine aminotransferase increased
6%
Immature granulocyte count 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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1050
Find a Location
Who is running the clinical trial?
Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,573 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
260 Previous Clinical Trials
55,991 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