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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

Must not have

Have prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic leukemia (T- LBL/T-ALL).

Major surgery within 4 weeks before the first dose of study treatment. Participants must have recovered from surgery prior to enrollment to this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of two years.

Awards & highlights

Pivotal Trial

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.

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.

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 below

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I am not pregnant or breastfeeding.

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I am 18 or older with advanced Epithelioid Sarcoma that cannot be surgically removed.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of T-cell lymphoblastic lymphoma or leukemia.

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I have recovered from major surgery that occurred more than 4 weeks ago.

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I have previously been treated with tazemetostat or similar medications.

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I am not taking strong medications that affect liver enzymes or St. John's Wort.

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My cancer has spread to my brain or its coverings.

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I am not pregnant or breastfeeding.

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I have a cancer type other than soft tissue sarcoma (STS) or Ewing sarcoma (ES).

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I am allergic to tazemetostat or doxorubicin.

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I have a history of blood cancer, such as MDS or AML.

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I have received cancer treatment through medication.

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I do not have any health conditions that make doxorubicin unsafe for me.

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I am currently being treated for an infection.

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I have had a solid organ transplant.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicities (DLTs)

Progression free survival (PFS)

Secondary study objectives

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)

+6 more

Side effects data

From 2021 Phase 2 trial • 20 Patients • NCT03456726

53%

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

Phlebitis

Aspartate aminotransferase increased

Blood zinc decreased

Haematuria

Electrocardiogram QT prolonged

Traumatic intracranial haemorrhage

Visual field defect

Skin exfoliation

Oedema peripheral

Gastroenteritis

Impetigo

Osteonecrosis of jaw

Hypogammaglobulinaemia

Rash maculo-papular

Nail disorder

Pyrexia

Myalgia

Gamma-glutamyltransferase increased

Insomnia

Hypertonic bladder

Fatigue

Traumatic fracture

Upper respiratory tract inflammation

Blood pressure decreased

Hypoalbuminaemia

Musculoskeletal chest pain

Gastric cancer

Non-small cell lung cancer

Haematochezia

Tooth disorder

Bronchitis

Abdominal pain

Large intestine polyp

Pneumocystis jirovecii pneumonia

Alanine aminotransferase increased

Immature granulocyte count increased

Cataract

Mechanical ileus

Atypical pneumonia

Periodontitis

Pneumonia aspiration

Leukopenia

Pericardial effusion

Conjunctival haemorrhage

Visual impairment

Epigastric discomfort

Oral herpes

Paronychia

Fall

Postoperative delirium

Procedural pain

Skin laceration

Tooth fracture

Hyperglycaemia

Hyperkalaemia

Hyperuricaemia

Pain in extremity

Tendon disorder

Myelodysplastic syndrome

Muscle spasticity

Peripheral motor neuropathy

Sciatica

Syncope

Asthma

Dysphonia

Erythema multiforme

Keloid scar

100%

80%

60%

40%

20%

Study treatment Arm

Participants With Follicular Lymphoma

Participants With Diffuse Large B-cell Lymphoma

Awards & Highlights

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

2016

Completed Phase 2

~1050

0 / 16Eligibility criteria met