What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as chemotherapy with paclitaxel and carboplatin, can cause side effects including neurotoxicity, granulocytopenia, anemia, fatigue, nausea, and hair loss. Targeted therapies like PARP inhibitors (e.g., olaparib) may lead to nausea, fatigue, anemia, and increased infection risk. Tazemetostat, which inhibits tumor cell growth, can cause fatigue, nausea, and has potential teratogenic effects, necessitating effective contraception during treatment.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of ovarian cancer that work by inhibiting tumor cell growth, similar to tazemetostat. These include chemotherapeutic agents like paclitaxel and carboplatin, which kill cancer cells and prevent their division. Additionally, targeted therapies such as bevacizumab, a monoclonal antibody that inhibits angiogenesis, and PARP inhibitors like olaparib, niraparib, and rucaparib, which prevent cancer cells from repairing their DNA, have also been approved. These treatments aim to control tumor growth and spread, offering various mechanisms to combat ovarian cancer.

What other types of research exist?

Promising novel alternatives to Tazemetostat for ovarian cancer treatment in 2024 include: 1) PARP inhibitors such as Olaparib, Niraparib, and Rucaparib, which are effective in patients with BRCA mutations or homologous recombination deficiency. 2) Anti-angiogenic agents like Bevacizumab, which inhibit tumor blood vessel growth. 3) Immune checkpoint inhibitors such as Pembrolizumab, which enhance the immune system's ability to target cancer cells. 4) Combination therapies involving these agents, which may offer synergistic effects and improved outcomes.

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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 below

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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.

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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.

Exclusion Criteria

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

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I have been treated with an experimental EZH2 inhibitor before.

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I have had a blood disorder like MDS before.

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My tests show genetic changes linked to certain blood disorders.

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

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I haven't taken drugs that strongly affect liver enzymes in the last 14 days.

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I am HIV positive and on combination antiretroviral therapy.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Tumor response

Secondary study objectives

Incidence of adverse events

Overall survival

Progression-free survival

+1 more

Other study objectives

ARID1A mutational status

BAF250a expression

Side effects data

From 2021 Phase 2 trial • 20 Patients • NCT03456726

53%

Dysgeusia

41%

Nasopharyngitis

29%

Blood creatine phosphokinase increased

29%

Upper respiratory tract infection

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

Upper respiratory tract inflammation

Traumatic fracture

Aspartate aminotransferase increased

Blood zinc decreased

Haematuria

Electrocardiogram QT prolonged

Skin exfoliation

Oedema peripheral

Hypoalbuminaemia

Fatigue

Gastroenteritis

Impetigo

Blood pressure decreased

Visual field defect

Osteonecrosis of jaw

Hypogammaglobulinaemia

Rash maculo-papular

Phlebitis

Nail disorder

Pyrexia

Myalgia

Gamma-glutamyltransferase increased

Insomnia

Traumatic intracranial haemorrhage

Hypertonic bladder

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

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

0 / 15Eligibility criteria met

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.