Tazemetostat for Tumors, Solid

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prisma Health Cancer Institute, Greenville, SC
Tumors, Solid+2 More
Tazemetostat - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug that inhibits EZH2 can lead to clinical benefit in patients with ARID1A mutated malignancies.

See full description

Eligible Conditions

  • Tumors, Solid
  • ARID1A Gene Mutation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Tazemetostat will improve 1 primary outcome and 1 secondary outcome in patients with Tumors, Solid. Measurement will happen over the course of through study completion, estimated to be 1 year after the last subject enrolled.

Year 1
Disease Control Rate
Overall Response Rate

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Part 1 (Pharmacokinetics)
Dyspnoea
54%
Nausea
46%
Fatigue
31%
Back pain
23%
Cancer pain
23%
Dysphonia
15%
Cough
15%
Abdominal Distension
15%
Decreased appetite
15%
Pleural effusion
15%
Vomiting
15%
Lymphocyte count decreased
15%
Night sweats
8%
Throat Irritation
8%
Upper respiratory Tract Infection
8%
Dermatitis acneiform
8%
Haemorrhoids
8%
Insomnia
8%
Arthralgia
8%
Ascites
8%
Oral candidiasis
8%
Hypokalaemia
8%
Abdominal pain
8%
Asthenia
8%
Hyperglycaemia
8%
Dry skin
8%
Gastrooesophageal Reflux Disease
8%
Epistaxis
8%
Hypophosphataemia
8%
Dyspepsia
8%
Rash
8%
Pleural Effusion
8%
Procedural pain
8%
Neuralgia
8%
Dermal cyst
8%
Embolism
8%
Dysphagia
8%
Chills
8%
Pyrexia
8%
Oedema peripheral
8%
Renal failure
0%
Lower respiratory tract infection
0%
Muscle spasms
0%
Dysgeusia
0%
Constipation
0%
Deep vein thrombosis
0%
Dizziness
0%
Urinary tract infection
0%
Hyponatraemia
0%
Pneumoperitoneum
0%
Oxygen saturation decreased
0%
Squamous cell carcinoma of skin
0%
Electrocardiogram T wave inversiontion
0%
Sepsis
0%
Pericardial Effusion
0%
Liver abscess
0%
Electrocardiogram ST segment elevation
0%
Air embolism
0%
Pneumonia
0%
Peritonitis
0%
Intestinal perforation
0%
Systemic infection
0%
Incarcerated umbilical hernia
0%
General physical health deterioration
0%
Syncope
0%
Malignant ascites
0%
Cancer Pain
0%
Weight decreased
0%
Anaemia
0%
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02860286) in the Part 1 (Pharmacokinetics) ARM group. Side effects include: Dyspnoea with 54%, Nausea with 46%, Fatigue with 31%, Back pain with 23%, Cancer pain with 23%.

Trial Design

1 Treatment Group

Tazemetostat
1 of 1
Experimental Treatment

This trial requires 40 total participants across 1 different treatment group

This trial involves a single treatment. Tazemetostat is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Tazemetostat
Drug
tazemetostat 800 mg po twice daily in continuous 28- day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, estimated to be 1 year after the last subject enrolled
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, estimated to be 1 year after the last subject enrolled for reporting.

Closest Location

Prisma Health Cancer Institute - Greenville, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Tumors, Solid or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A tumor that has been confirmed to have advanced or metastatic cancer, and that also has a mutation in the ARID1A gene, except for epithelioid sarcoma. show original
The progression of the disease can vary depending on the therapy that is used or if there is not a standard therapy available. show original
The text states that any clinically significant toxicity related to a prior anticancer treatment (i.e., chemotherapy, immunotherapy, and/or radiotherapy) must have resolved to grade 1 per NCI CTCAE Version 5.0 OR be clinically stable and no longer clinically significant at the time the subject provides voluntary written informed consent. show original
The person's life expectancy is more than three months before they enroll in the program. show original
A patient is classified as having an ECOG performance status of 0 if they are fully active and able to carry out all normal activities show original
Any person over the age of 18 can provide written consent for themselves. show original
Patients undergoing cytotoxic chemotherapy must wait at least 21 days before starting a noncytotoxic chemotherapy regimen show original
Creatinine levels must be below 2.0 to ensure adequate renal function show original
Have agreed to provide written consent and agreed to comply with all aspects of the protocol. show original
The individual has cancer that can be measured using the RECIST 1.1 scale. show original

Patient Q&A Section

Can cancer be cured?

"No cures exist for any form of cancer (cancer cells persist for hundreds of thousands of years). The best one can hope for is a cure for a tiny percentage of people. What people choose to do next is up to themselves.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"The most common signs in cancer are erythema and scaling, and loss of weight. These signs are more common in older individuals, with a male predominance with cancer." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"The cause of cancer is complicated and multi-factorial, involving environmental (for example, alcohol and chemicals), genetic (for example, inherited risk genes), and epigenetic factors, as well as biological (for example, cancer stem cells). However, we do not possess the technology to fully explore every possible mechanism that might cause cancer." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is a group of diseases that may form in any organ. Cancer is made up of many different kinds of cells that grow out of control and invade neighboring tissues, forming a mass of cells. This cancerous growth will invade additional tissues unless it is eliminated by the immune system. Each kind of cell in a mass of cells is unique. For almost all cancer patients, it takes many types of specialized cells to form a tumor." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"Cancer treatment is often by surgical resection or other approaches such as chemotherapy or radiation. In some cases, such as sarcoma, surgery continues to be indicated. In other cases such as multiple myeloma, it may become unnecessary, as will be discussed. Radiotherapy continues to be a mainstay in the treatment of a wide variety of cancers." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"Approximately 2.8 million cases of cancer is diagnosed yearly in the United States. Lung cancer (1/6), and cancer of the breast are two cancers that are the most common cause of cancer related deaths." - Anonymous Online Contributor

Unverified Answer

How does tazemetostat work?

"Tazemetostat is a novel histone deacetylase inhibitor that merits further investigation for its potential for treating non-Hodgkin's lymphoma. This drug acts by deacetylating histones with a preference for hypoacetylated lysine residues in promoters of tumor cells, allowing transcription factors to bind to the DNA, activating genes that make tumor cells more likely to grow and divide." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer?

"If we accept the conclusion of the scientific establishment that there aren’t new discoveries to treat any of the known forms of cancer, then it must be accepted that current treatments only treat the symptoms caused by the cancer, and that is a real disappointment, as it would imply that we know so little about cancer that no better drug or chemotherapy could be created. The fact that our current treatments cannot cure this disease would be more of a setback than just being told there is no new treatments whatsoever." - Anonymous Online Contributor

Unverified Answer

Does tazemetostat improve quality of life for those with cancer?

"Patients with cancer treated with tazemetostat demonstrated improvement in QOL for several parameters of global QOL, fatigue, pain, and sleep disorders. The overall burden of these symptoms remains high and therefore should be addressed on a daily basis within the treatment strategy for cancer." - Anonymous Online Contributor

Unverified Answer

What is tazemetostat?

"Tazemetostat demonstrates an array of activities that are of interest to academic scientists. Its mode of action involves, but is not limited to, inhibition of several enzymes in both the cytosol and mitochondria. Importantly, it appears to be a novel member of the HDACi family of drugs, and this property makes it a valuable tool for dissecting HDAC activities in cells. In addition, tazemetostat has been proven to be an effective therapeutic agent." - Anonymous Online Contributor

Unverified Answer

Has tazemetostat proven to be more effective than a placebo?

"Tazemetostat had no additional antitumor activity but did prevent peripheral blast transformation of myeloid progenitors, which is considered toxic and has led to its withdrawal from the market in the recent past. When used as a mono, the risk of hematological toxicity outweighed any potential benefit." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer?

"There is no doubt that cancer is a major and a highly growing issue at all levels of society. With regard to the medical profession, the medical world is undergoing a transformation, and with the advances in understanding, treatment and prevention of cancer are a step closer to reality. Recent research for cancer focuses on how to control the mutated cells that are responsible for their growth. With new techniques and therapies, cancer patients are beginning to enjoy a relatively better life expectancy. However, as of yet there is no cure for some of the more dangerous forms of cancer, such as the leukemia cell. However, the most common form of cancer (cervical or cervical cancer) was found to be under control within the past 10 years." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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