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Epigenetic Therapy
Tazemetostat for Ovarian or Endometrial Cancer
Phase 2
Waitlist Available
Led By Ramez N Eskander
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be able to swallow and retain oral medications
Pathologically proven diagnosis of recurrent or persistent ovarian endometrioid or clear cell carcinoma, OR recurrent or persistent endometrioid endometrial adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial looks at how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back.
Who is the study for?
This trial is for adults with recurrent ovarian or endometrial cancer, specifically endometrioid or clear cell types. Participants must have completed prior treatments and be able to take oral medication. They should not be pregnant, have severe co-morbidities, bowel obstruction, HIV on antiretrovirals, a history of myeloid malignancies or recent therapeutic paracentesis.Check my eligibility
What is being tested?
The trial tests Tazemetostat's effectiveness in treating recurrent ovarian or endometrial cancer. It's a phase II study where the drug aims to stop tumor growth by killing cells or preventing their division and spread. Imaging techniques like MRI and CT scans are used for evaluation.See study design
What are the potential side effects?
While specific side effects of Tazemetostat aren't listed here, chemotherapy drugs can generally cause fatigue, nausea, hair loss, increased risk of infection due to low blood counts and may affect liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
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My cancer is a recurring or persistent ovarian or endometrial type.
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My recurrent endometrial cancer has been tested for MMR.
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My ovarian cancer has a specific genetic change known as ARID1A mutation.
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My ovarian tumor is mostly made up of endometrioid or clear cell types.
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I am 18 years old or older.
Select...
I am able to care for myself and perform daily activities.
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I have finished all my previous cancer treatments, including chemotherapy and immunotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor response
Secondary outcome measures
6-month progression free survival (clinical benefit rate)
Incidence of adverse events
Overall survival
+2 moreOther outcome measures
ARID1A mutational status
BAF250a expression
Side effects data
From 2021 Phase 2 trial • 20 Patients • NCT0345672653%
Dysgeusia
41%
Nasopharyngitis
29%
Blood creatine phosphokinase increased
29%
Upper respiratory tract infection
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
24%
Rash
18%
Thrombocytopenia
18%
Blood creatinine increased
18%
Neutropenia
18%
Weight decreased
18%
Nausea
12%
Herpes simplex
12%
Influenza
12%
Urinary tract infection
12%
Amylase increased
12%
Pneumonia
12%
Malaise
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Gastric cancer
6%
Non-small cell lung cancer
6%
Abdominal pain
6%
Haematochezia
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%
Electrocardiogram QT prolonged
6%
Hypoalbuminaemia
6%
Aspartate aminotransferase increased
6%
Visual field defect
6%
Skin exfoliation
6%
Pneumocystis jirovecii pneumonia
6%
Nail disorder
6%
Rash maculo-papular
6%
Traumatic intracranial haemorrhage
6%
Tooth disorder
6%
Large intestine polyp
6%
Pyrexia
6%
Myalgia
6%
Haematuria
6%
Phlebitis
6%
Insomnia
6%
Bronchitis
6%
Upper respiratory tract inflammation
6%
Impetigo
6%
Hypogammaglobulinaemia
6%
Osteonecrosis of jaw
6%
Musculoskeletal chest pain
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
1Treatment groups
Experimental Treatment
Group I: Treatment (tazemetostat)Experimental Treatment3 Interventions
Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Tazemetostat
2016
Completed Phase 2
~780
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,091 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
100,790 Total Patients Enrolled
Ramez N EskanderPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
759 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test results show no major abnormalities in how your blood cells look.My cancer stage fits the study requirements.Your white blood cell count is at least 1,500 per microliter.I have another cancer type, but it won't affect this trial's treatment.All patients must have a measurable tumor according to specific guidelines.I have had 1 to 3 chemotherapy treatments for my primary cancer.Your hemoglobin level is at least 8 grams per deciliter.Your AST and ALT levels are not more than 3 times the upper limit of normal.Your bilirubin levels in the blood need to be within a certain range. If it's higher than that range, you may not be able to participate.I have a history of T-cell lymphoblastic lymphoma or leukemia.I haven't taken drugs that strongly affect liver enzymes in the last 14 days.My cancer is a recurring or persistent ovarian or endometrial type.My recurrent endometrial cancer has been tested for MMR.My ovarian cancer has a specific genetic change known as ARID1A mutation.I have had a blood disorder like MDS before.I can swallow and keep down pills.I have been treated with an experimental EZH2 inhibitor before.My tests show genetic changes linked to certain blood disorders.Your creatinine level is not higher than 1.5 times the normal limit at the lab.You have a platelet count of at least 100,000 per microliter.You have a serious health condition, as determined by the doctor in charge of the study.I am HIV positive and on combination antiretroviral therapy.My ovarian tumor is mostly made up of endometrioid or clear cell types.I am 18 years old or older.I am able to care for myself and perform daily activities.I have signs of a blockage in my intestines.I have finished all my previous cancer treatments, including chemotherapy and immunotherapy.I have had fluid removed from my abdomen or chest in the last 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are a part of this clinical trial?
"Unfortunately, this particular clinical study is not currently looking for new participants. The trial was initially posted on 3/29/2019 and updated on 9/23/2022. However, there are 4034 other studies actively enrolling patients with malignant neoplasms and 20 trials for Tazemetostat that are still recruiting patients at this time."
Answered by AI
What is the current governmental stance on Tazemetostat?
"Tazemetostat is a phase 2 medication, so while there is some data supporting its safety, none of it suggests that the drug is effective."
Answered by AI
Are there many hospitals running this trial in Canada?
"The primary sites for this clinical trial are Providence Saint Mary Regional Cancer Center in Walla Walla, Washington, Aurora Health Care Germantown Health Center in Germantown, Wisconsin and ProMedica Flower Hospital in Sylvania, Michigan. There are also 100 other locations where the trial is being conducted."
Answered by AI
Is Tazemetostat a common drug in research?
"Tazemetostat was first studied in 2015 at the Sarcoma Center HELIOS Klinikum Berlin. As of now, 578 trials have been completed with 20 more actively recruiting patients. The majority of these active trials are situated in Walla Walla, Washington."
Answered by AI
Have these types of trials been conducted before?
"As of now, there are 20 ongoing studies for Tazemetostat in 533 cities and 21 countries. The first clinical trial was sponsored by Epizyme, Inc. in 2015 and it completed its Phase 2 drug approval stage with data from 250 patients. In the last 6 years, 578 trials have been conducted worldwide."
Answered by AI
Are people still being signed up for this experiment?
"According to the website, this clinical trial is not looking for patients at this time. The study was originally posted on 3/29/2019 and updated on 9/23/2022. Although this particular trial has closed recruitment, there are 4054 other trials that are currently searching for participants."
Answered by AI
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