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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
Must not have
Prior treatment with an investigational EZH2 inhibitor
A prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back. Tazemetostat aims to stop cancer cells from growing and spreading. The trial targets patients whose cancers have returned after initial treatment.
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.
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.
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.
Select...
My cancer is a recurring or persistent ovarian or endometrial type.
Select...
My recurrent endometrial cancer has been tested for MMR.
Select...
My ovarian cancer has a specific genetic change known as ARID1A mutation.
Select...
My ovarian tumor is mostly made up of endometrioid or clear cell types.
Select...
I am 18 years old or older.
Select...
I am able to care for myself and perform daily activities.
Select...
I have finished all my previous cancer treatments, including chemotherapy and immunotherapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with an experimental EZH2 inhibitor before.
Select...
I have had a blood disorder like MDS before.
Select...
My tests show genetic changes linked to certain blood disorders.
Select...
I have a history of T-cell lymphoblastic lymphoma or leukemia.
Select...
I haven't taken drugs that strongly affect liver enzymes in the last 14 days.
Select...
I am HIV positive and on combination antiretroviral therapy.
Select...
I have signs of a blockage in my intestines.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tumor response
Secondary study objectives
Incidence of adverse events
Overall survival
Progression-free survival
+1 moreOther study objectives
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%
Blood creatinine increased
18%
Weight decreased
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
6%
Aspartate aminotransferase increased
6%
Blood zinc decreased
6%
Rash maculo-papular
6%
Traumatic intracranial haemorrhage
6%
Hypoalbuminaemia
6%
Haematuria
6%
Electrocardiogram QT prolonged
6%
Upper respiratory tract inflammation
6%
Oedema peripheral
6%
Traumatic fracture
6%
Phlebitis
6%
Fatigue
6%
Gastroenteritis
6%
Impetigo
6%
Blood pressure decreased
6%
Osteonecrosis of jaw
6%
Visual field defect
6%
Skin exfoliation
6%
Hypogammaglobulinaemia
6%
Nail disorder
6%
Pyrexia
6%
Myalgia
6%
Insomnia
6%
Hypertonic bladder
6%
Gamma-glutamyltransferase increased
6%
Musculoskeletal chest pain
6%
Gastric cancer
6%
Non-small cell lung cancer
6%
Haematochezia
6%
Tooth disorder
6%
Bronchitis
6%
Abdominal pain
6%
Large intestine polyp
6%
Pneumocystis jirovecii pneumonia
6%
Alanine aminotransferase increased
6%
Immature granulocyte count 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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Computed Tomography
2017
Completed Phase 2
~2740
Tazemetostat
2016
Completed Phase 2
~1050
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ovarian cancer, such as chemotherapy, work by targeting rapidly dividing cells. Agents like paclitaxel and carboplatin disrupt cell division and induce cell death, effectively reducing tumor size and spread.
Targeted therapies, including PARP inhibitors, exploit specific genetic weaknesses in cancer cells to prevent DNA repair, leading to cell death. These mechanisms are crucial for ovarian cancer patients as they directly attack the cancer cells' ability to grow and spread, offering a chance to control the disease and improve survival rates.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,886 Previous Clinical Trials
41,020,875 Total Patients Enrolled
292 Trials studying Ovarian Cancer
76,948 Patients Enrolled for Ovarian Cancer
NRG OncologyOTHER
237 Previous Clinical Trials
102,712 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.
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