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.

Epigenetic Therapy

Tazemetostat for Ovarian or Endometrial Cancer

Anchorage, AK

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 overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months).

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.

See full description

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 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.

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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.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months). 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

6-month Progression Free Survival (Clinical Benefit Rate)

Number of Patients With a Grade 3 (or Higher) Adverse Events

Overall Survival

+2 more

Other study objectives

ARID1A Mutational Status

BAF250a Expression

Side effects data

From 2024 Phase 2 trial • 20 Patients • NCT03213665

50%

Fatigue

45%

Anemia

45%

Vomiting

40%

Lymphocyte count decreased

40%

Hyperglycemia

35%

Nausea

35%

White blood cell decreased

35%

Hypocalcemia

30%

Disease progression

30%

Hyponatremia

30%

Abdominal pain

30%

Platelet count decreased

25%

Fever

25%

Alanine aminotransferase increased

25%

Aspartate aminotransferase increased

25%

Hypoalbuminemia

25%

Pain in extremity

20%

Hypokalemia

20%

Irritability

20%

Pain

20%

Alkaline phosphatase increased

20%

Headache

15%

Hypophosphatemia

15%

Blood bilirubin increased

15%

Diarrhea

15%

Hypermagnesemia

15%

Neutrophil count decreased

15%

Anorexia

15%

Hyperphosphatemia

15%

Dyspnea

15%

Alopecia

15%

Hypertension

10%

Eosinophilia

10%

Abdominal distension

10%

Constipation

10%

Respiratory failure

10%

Hypomagnesemia

10%

Lung infection

10%

Generalized edema

10%

Skin infection

10%

Edema face

10%

Hydrocephalus

10%

Hypoxia

10%

Weight gain

10%

Hypernatremia

10%

Back pain

10%

Neck pain

10%

Somnolence

10%

Insomnia

10%

Cough

10%

Nasal congestion

10%

Creatinine increased

10%

Productive cough

10%

Respiratory, thoracic and mediastinal disorders - Other, specify

10%

Dry skin

Seizure

Spinal cord compression

Palpitations

Sinus bradycardia

Sinus tachycardia

Urinary tract infection

Pneumothorax

Thrombotic thrombocytopenic purpura

Bone pain

Muscle weakness upper limb

Facial muscle weakness

Dysuria

Urine discoloration

Cushingoid

Endocrine disorders - Other, specify

Dry mouth

Mucositis/stomatitis (functional/symptomatic) - Oral cavity

Edema limbs

Gait disturbance

Hypothermia

Non-cardiac chest pain

Upper respiratory infection

Wound infection

Burn

Injury, poisoning and procedural complications - Other, specify

Wound dehiscence

Dehydration

Hypothyroidism

Gastroesophageal reflux disease

Stomach pain

Dysphagia

Intracranial hemorrhage

Muscle weakness right-sided

Investigations - Other, specify

Hyperkalemia

Hypoglycemia

Arthralgia

Chest wall pain

Generalized muscle weakness

Muscle weakness lower limb

Cerebrospinal fluid leakage

Dysarthria

Dysgeusia

Facial nerve disorder

Lethargy

Nystagmus

Oculomotor nerve disorder

Anxiety

Confusion

Depression

Renal and urinary disorders - Other, specify

Urinary retention

Epistaxis

Pleural effusion

Fibrinogen decreased

GGT increased

Erythema multiforme

Nail changes

Rash maculo-papular

Skin and subcutaneous tissue disorders - Other, specify

Skin hyperpigmentation

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Tazemetostat)

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

Tazemetostat

2016

Completed Phase 2

~1110

Computed Tomography

2017

Completed Phase 2

~2440

Magnetic Resonance Imaging

2020

Completed Phase 3

~1180

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.