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Anti-tumor antibiotic
Tazemetostat + Doxorubicin for 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
Females must not be lactating or pregnant at Screening or Baseline
Phase 3: ≥18 years old with unresectable locally advanced or metastatic Epithelioid Sarcoma and tumor tissue available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of two years.
Awards & highlights
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.
Who is the study for?
Adults with advanced epithelioid sarcoma, a rare soft-tissue cancer, are eligible for this trial if they have measurable disease and an expected lifespan of at least 3 months. They must be able to perform daily activities with minimal assistance (ECOG status 0-2) and have proper organ function. Women can't be pregnant/breastfeeding and along with men, must use effective contraception. Those with HIV may join if well-controlled on therapy. Exclusions include active hepatitis B/C infections, other major illnesses that could interfere with the study, prior cancer treatments or conditions affecting drug absorption.Check my eligibility
What is being tested?
The trial is testing tazemetostat in combination with doxorubicin against a placebo combined with doxorubicin in patients who haven't had previous systemic anticancer therapy. Part 1 focuses on determining the safest dose level while part 2 compares how long patients live without their disease worsening using these combinations.See study design
What are the potential side effects?
Possible side effects from tazemetostat may include fatigue, nausea, constipation, coughing and shortness of breath among others. Doxorubicin can cause hair loss, mouth sores, vomiting and heart damage in some cases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding.
Select...
I am 18 or older with advanced Epithelioid Sarcoma that cannot be surgically removed.
Select...
I am able to care for myself and perform daily activities.
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%
Upper respiratory tract infection
29%
Blood creatine phosphokinase increased
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
24%
Rash
18%
Thrombocytopenia
18%
Weight decreased
18%
Blood creatinine increased
18%
Neutropenia
18%
Nausea
12%
Urinary tract infection
12%
Influenza
12%
Pneumonia
12%
Amylase increased
12%
Herpes simplex
12%
Malaise
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Fatigue
6%
Oedema peripheral
6%
Blood pressure decreased
6%
Traumatic intracranial haemorrhage
6%
Gastric cancer
6%
Non-small cell lung cancer
6%
Aspartate aminotransferase increased
6%
Myalgia
6%
Gastroenteritis
6%
Immature granulocyte count increased
6%
Nail disorder
6%
Blood zinc decreased
6%
Gamma-glutamyltransferase increased
6%
Skin exfoliation
6%
Haematochezia
6%
Pyrexia
6%
Hypogammaglobulinaemia
6%
Electrocardiogram QT prolonged
6%
Hypoalbuminaemia
6%
Abdominal pain
6%
Bronchitis
6%
Pneumocystis jirovecii pneumonia
6%
Large intestine polyp
6%
Haematuria
6%
Visual field defect
6%
Insomnia
6%
Phlebitis
6%
Tooth disorder
6%
Osteonecrosis of jaw
6%
Impetigo
6%
Traumatic fracture
6%
Hypertonic bladder
6%
Upper respiratory tract inflammation
6%
Musculoskeletal chest pain
6%
Rash maculo-papular
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
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
2016
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,762 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
257 Previous Clinical Trials
55,053 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of T-cell lymphoblastic lymphoma or leukemia.I have recovered from major surgery that occurred more than 4 weeks ago.My blood, kidney, and liver tests meet the required levels.I am not taking strong medications that affect liver enzymes or St. John's Wort.I am willing to avoid Seville oranges, grapefruit, and their derivatives during the study.I cannot take pills or have a condition that affects how my body uses medication.I have not taken part in a drug trial within the last 30 days or 5 half-lives of the drug.My cancer has spread to my brain or its coverings.I have HIV but it is well controlled with medication.I have previously been treated with tazemetostat or similar medications.I am not pregnant or breastfeeding.I have a cancer type other than soft tissue sarcoma (STS) or Ewing sarcoma (ES).I am a man who either had a vasectomy or uses effective birth control.I am not pregnant or breastfeeding.I am not pregnant or breastfeeding and agree to use effective birth control during and 6 months after the trial.I am between 18 and 65 years old with a confirmed diagnosis of Soft Tissue Sarcoma.I am allergic to tazemetostat or doxorubicin.I am 18 or older with advanced Epithelioid Sarcoma that cannot be surgically removed.I have a history of blood cancer, such as MDS or AML.I have received cancer treatment through medication.I do not have any health conditions that make doxorubicin unsafe for me.I am currently being treated for an infection.I have had a solid organ transplant.I am able to care for myself and perform daily activities.You have a weakened immune system, either from birth or due to a medical condition.I have a heart condition as described in the study details.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 3: Placebo + Doxorubicin Arm
- Group 2: Phase 1b: Open-label Tazemetostat and Phase 3: Tazemetostat + Doxorubicin Arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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
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