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Epigenetic Modifier
Tazemetostat for Cancer
Phase 1
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1, part 1: days 1-39 of the 39-day cycle. cycle 1, part 2: days 1-26 of the 26-day cycle. cycle 2+: day 1 (±3 days) of every 28-day cycle. end of study: 30 (±3) days after last dose of study drug. annual assessments: yearly from day 1 of cycle 1.
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Eligible Conditions
- Advanced Cancers
- Synovial Sarcoma
- Blood Cancers
- Cancer
- Mesothelioma
- Solid Tumors
- Non-Hodgkin's Lymphoma
- Renal Medullary Carcinoma
- Follicular Lymphoma
- Rhabdoid Tumor
- Epithelioid Sarcoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1, part 1: days 1-39 of the 39-day cycle. cycle 1, part 2: days 1-26 of the 26-day cycle. cycle 2+: day 1 (±3 days) of every 28-day cycle. end of study: 30 (±3) days after last dose of study drug. annual assessments: yearly from day 1 of cycle 1.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1, part 1: days 1-39 of the 39-day cycle. cycle 1, part 2: days 1-26 of the 26-day cycle. cycle 2+: day 1 (±3 days) of every 28-day cycle. end of study: 30 (±3) days after last dose of study drug. annual assessments: yearly from day 1 of cycle 1.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: PK of tazemetostat administered as a single and twice daily: area under the plasma concentration-time curve from time 0 to 72 hours post-dose (AUC0-72)
Part 1: PK of tazemetostat administered as a single and twice daily: observed maximum plasma of concentration (Cmax)
Part 1: Pharmacokinetics (PK) of tazemetostat administered as a single and twice daily: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
+3 moreSecondary outcome measures
Concomitant medication monitoring
Number of participants experiencing Adverse Events (AEs)
Part 1: PK of tazemetostat and its metabolites after administration alone and with itraconazole: AUC0-t
+13 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%
Neutropenia
18%
Blood creatinine increased
18%
Weight decreased
18%
Nausea
12%
Influenza
12%
Urinary tract infection
12%
Herpes simplex
12%
Pneumonia
12%
Amylase increased
12%
Malaise
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Gastric cancer
6%
Abdominal pain
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%
Aspartate aminotransferase increased
6%
Non-small cell lung cancer
6%
Haematochezia
6%
Pyrexia
6%
Hypogammaglobulinaemia
6%
Electrocardiogram QT prolonged
6%
Hypoalbuminaemia
6%
Musculoskeletal chest pain
6%
Haematuria
6%
Visual field defect
6%
Pneumocystis jirovecii pneumonia
6%
Nail disorder
6%
Traumatic intracranial haemorrhage
6%
Large intestine polyp
6%
Myalgia
6%
Phlebitis
6%
Insomnia
6%
Bronchitis
6%
Upper respiratory tract inflammation
6%
Impetigo
6%
Tooth disorder
6%
Skin exfoliation
6%
Osteonecrosis of jaw
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
Group I: Part 2:Tazemetostat and Rifampin Drug Interaction Cycle 1Experimental Treatment2 Interventions
Participants in Part 2 of the study will receive a single oral, 800 mg dose of tazemetostat on Days 1, 15, and Day 36.
The study participants will receive tazemetostat (oral 800 mg dose) tablets to be taken twice daily on Days 3 - 14 and Days 17 - 23. In addition, the participants will receive oral 200 mg rifampin once daily on Days 17 - 25.
Study participants may continue tazemetostat from Day 27+ at the recommended therapeutic dose (oral 800 mg twice daily) in 28-day cycles.
Group II: Part 1: Tazemetostat and Itraconazole Drug Interaction Cycle 1Experimental Treatment2 Interventions
Participants in Part 1 of the study will receive a single oral, 400 mg dose of tazemetostat on Day 1, 15, and Day 36.
The study participants will receive tazemetostat (oral 400 mg) tablets to be taken twice daily on Days 3 - 14 and Days 21 - 35. In addition, the participants will receive oral 200 mg itraconazole once daily on Days 18 - 38.
Study participants may continue tazemetostat from Day 40+ at the recommended therapeutic dose (oral 800 mg twice daily) in 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifampin
2011
Completed Phase 3
~2140
Itraconazole
2017
Completed Phase 2
~780
Tazemetostat
2016
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,812 Total Patients Enrolled
Ipse Medical DirectorStudy DirectorIpsen
1 Previous Clinical Trials
34 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Tazemetostat been cleared by the FDA?
"While there is only limited data supporting the safety and efficacy of Tazemetostat, our team at Power still estimates the safety of the medication to be a 1."
Answered by AI
What is the main reason that Tazemetostat is prescribed?
"Tazemetostat is not only used to treat onychomycosis, but also other fungal infections like coccidioides and initial phase tuberculosis. Additionally, this medication can be helpful for treating pruritus."
Answered by AI
What other research studies have been undertaken that focus on Tazemetostat?
"Tazemetostat was first researched in 2011 at Hadassah Hebrew University Medical Center. Since the beginning of the drug's conception, there have been a total of 435 completed trials. Right now, there are 65 live clinical trials being conducted with many of them located in Los Angeles, California."
Answered by AI
Are there any available enrolment slots for new participants?
"Unfortunately, this study is not presently looking for candidates as of May 20th, 2022. The clinical trial was originally posted on April 23rd, 2020. Although this trial is not enrolling candidates anymore, there are 4994 other trials currently recruiting participants."
Answered by AI
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