Anti-tumor antibiotic
Tazemetostat for Epithelioid Sarcoma
Phase 3
Recruiting
Research Sponsored by Epizyme, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase 3: ≥18 years old with unresectable locally advanced or metastatic Epithelioid Sarcoma and tumor tissue available
Phase 1b: 18-65 years old histologically confirmed Soft Tissue Sarcoma
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion, an average of two years.
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Study Summary
This trial is testing a new drug to treat a type of cancer called epithelioid sarcoma. The trial will have two parts and will compare the new drug to a placebo.
Eligible Conditions
- Advanced Epithelioid Sarcoma
- Soft Tissue Sarcoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are 18 years or older and have a type of sarcoma called Epithelioid Sarcoma that cannot be surgically removed. Additionally, you have tumor tissue available for testing.
Select...
You are between 18 and 65 years old and have been diagnosed with soft tissue sarcoma through a tissue sample examination.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicities (DLTs)
Progression free survival (PFS)
Secondary outcome measures
Change from baseline in European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQC-30)
Disease control rate (DCR)
Duration of treatment (DOR)
+14 moreSide effects data
From 2021 Phase 2 trial • 20 Patients • NCT0345672653%
Dysgeusia
41%
Nasopharyngitis
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
29%
Upper respiratory tract infection
29%
Blood creatine phosphokinase increased
24%
Rash
18%
Neutropenia
18%
Thrombocytopenia
18%
Nausea
18%
Blood creatinine increased
18%
Weight decreased
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Malaise
12%
Herpes simplex
12%
Influenza
12%
Pneumonia
12%
Urinary tract infection
12%
Amylase increased
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Mechanical ileus
6%
Pyrexia
6%
Atypical pneumonia
6%
Periodontitis
6%
Pneumocystis jirovecii pneumonia
6%
Traumatic intracranial haemorrhage
6%
Gastric cancer
6%
Non-small cell lung cancer
6%
Pneumonia aspiration
6%
Upper respiratory tract inflammation
6%
Leukopenia
6%
Pericardial effusion
6%
Conjunctival haemorrhage
6%
Cataract
6%
Visual impairment
6%
Abdominal pain
6%
Epigastric discomfort
6%
Haematochezia
6%
Large intestine polyp
6%
Tooth disorder
6%
Fatigue
6%
Oedema peripheral
6%
Hypogammaglobulinaemia
6%
Bronchitis
6%
Gastroenteritis
6%
Impetigo
6%
Oral herpes
6%
Paronychia
6%
Fall
6%
Postoperative delirium
6%
Procedural pain
6%
Skin laceration
6%
Tooth fracture
6%
Traumatic fracture
6%
Electrocardiogram QT prolonged
6%
Alanine aminotransferase increased
6%
Aspartate aminotransferase increased
6%
Blood pressure decreased
6%
Blood zinc decreased
6%
Gamma-glutamyltransferase increased
6%
Immature granulocyte count increased
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Hyperuricaemia
6%
Hypoalbuminaemia
6%
Musculoskeletal chest pain
6%
Myalgia
6%
Osteonecrosis of jaw
6%
Pain in extremity
6%
Tendon disorder
6%
Myelodysplastic syndrome
6%
Muscle spasticity
6%
Peripheral motor neuropathy
6%
Sciatica
6%
Syncope
6%
Visual field defect
6%
Insomnia
6%
Haematuria
6%
Hypertonic bladder
6%
Asthma
6%
Dysphonia
6%
Erythema multiforme
6%
Keloid scar
6%
Nail disorder
6%
Rash maculo-papular
6%
Skin exfoliation
6%
Phlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Participants With Follicular Lymphoma
Participants With Diffuse Large B-cell Lymphoma
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 1b: Open-label Tazemetostat and Phase 3: Tazemetostat + Doxorubicin ArmExperimental Treatment2 Interventions
Phase 1b: On cycle 1 day -1, participants will receive a single morning dose of tazemetostat at the assigned dose level. Participants will receive doxorubicin 75 mg/m2 intravenously (IV) on day 1 of each cycle for up to 6 cycles.
Tazemetostat will be escalated from a starting dose of 400 mg twice daily PO to 600 mg twice daily PO to 800 mg twice daily.
Phase 3:
Tazemetostat (800 mg) administered orally twice daily in continuous 21-day cycles during cycles 1-6 and in continuous 28-day cycles during cycle 7 and beyond.
Doxorubicin 75 mg/m2 IV on day 1 of cycles 1-6.
Group II: Phase 3: Placebo + Doxorubicin ArmPlacebo Group2 Interventions
Placebo administered orally twice daily in continuous 21-day cycles during cycles 1-6 and in continuous 28-day cycles during cycles 7 and beyond.
Doxorubicin 75 mg/m2 IV on day 1 of cycles 1-6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
FDA approved
Find a site
Who is running the clinical trial?
Epizyme, Inc.Lead Sponsor
32 Previous Clinical Trials
2,637 Total Patients Enrolled
Ipsen Medical DirectorStudy Director
Ipsen234 Previous Clinical Trials
53,058 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the desired patient population for this clinical trial?
"This clinical trial requires 164 individuals that fit the pre-determined inclusion criteria. Those interested in participating can do so at University of Michigan Medical Center located in Ann Arbor, Michigan or Sarah Cannon Research Institute at HealthONE in Denver, Colorado."
Answered by AI
Could you please tell me what other scientific research studies have been conducted that involve Tazemetostat?
"The first trial for tazemetostat was completed in 1997 at Spectrum Health Hospital - Butterworth Campus. As of right now, there have been a total of 18941 completed trials worldwide. There are currently 399 live trials, with a large concentration in Ann Arbor, Michigan."
Answered by AI
Is Tazemetostat a safe medication for people to take?
"Tazemetostat is rated as a 3 in terms of safety by our team at Power. This is because it is a Phase 3 trial, meaning that there is evidence from past trials to support both its efficacy and safety."
Answered by AI
To your knowledge, are there other studies like this one?
"Tazemetostat has had 399 ongoing trials in 67 countries and 1972 cities since 1997. The original study, sponsored by Alfacell, was a Phase 3 drug approval trial that involved 300 patients. Since the completion of that trial, 18941 more have been completed."
Answered by AI