40 Participants Needed

Tazemetostat for Solid Cancers

JK
JC
Overseen ByJulie C Martin, DNP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The FDA approved targeted agent tazemetostat inhibits EZH2 and induces durable tumor responses in patients with B-cell non-Hodgkin's lymphoma and epithelioid sarcomas. Responses have also been demonstrated in INI1 and SMARCA4 negative solid tumors patients. Since EZH2 plays a critical role in driving the biology of ARID1A mutated malignancies, we hypothesize that inhibition of EZH2 with tazemetostat will lead to significant clinical benefit in ARID1A mutated malignancies.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take medications that are known potent CYP3A4 inducers/inhibitors, like St. John's wort. There are also specific time requirements between prior anticancer therapies and starting the trial drug.

What data supports the idea that Tazemetostat for Solid Cancers is an effective drug?

The available research does not provide specific data on Tazemetostat for Solid Cancers. Instead, it discusses other treatments like Serdemetan, Tiragolumab, and Pemetrexed for various types of cancers. Without specific data on Tazemetostat, we cannot determine its effectiveness compared to these other treatments.12345

What safety data is available for Tazemetostat in treating solid cancers?

The provided research does not contain specific safety data for Tazemetostat or its other names. The studies mentioned focus on different compounds and their effects on various cancer types, but none of them evaluate Tazemetostat. For safety data on Tazemetostat, it would be necessary to look for studies or clinical trials specifically involving Tazemetostat or its synonyms.678910

Is the drug Tazemetostat promising for treating solid cancers?

The information provided does not directly mention Tazemetostat or its effectiveness for solid cancers. Therefore, based on the given data, we cannot determine if Tazemetostat is a promising treatment for solid cancers.1112131415

Research Team

Dr. Ki Young Chung, MD - Boiling ...

Ki Chung, MD

Principal Investigator

Prisma Health

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors that have an ARID1A mutation, excluding those with epithelioid sarcoma. Participants must have tried other treatments without success and should not be pregnant, breastfeeding, or have had major surgery recently. They need to be able to take oral medication and not have a history of certain cancers or severe heart conditions.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.
My condition worsened after treatment or no standard treatment is available for me.
My kidney function is good, with creatinine below 2.0 or clearance above 35 mL/min.
See 9 more

Exclusion Criteria

I do not have epithelioid sarcoma.
I need steroids for my uncontrolled brain metastases.
Are unwilling to exclude Seville oranges, grapefruit juice, AND grapefruit from their diet
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tazemetostat 800 mg orally twice daily in continuous 28-day cycles

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • Tazemetostat
Trial OverviewThe study tests Tazemetostat, an FDA-approved drug thought to benefit patients with specific tumor mutations by inhibiting a protein called EZH2. The goal is to see if this drug can provide significant clinical benefits in malignancies associated with the ARID1A mutation.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TazemetostatExperimental Treatment1 Intervention
tazemetostat 800 mg po twice daily in continuous 28- day cycles

Tazemetostat is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tazverik for:
  • Epithelioid sarcoma
  • Follicular lymphoma
🇪🇺
Approved in European Union as Tazverik for:
  • Epithelioid sarcoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials
91
Recruited
47,500+

Ipsen

Industry Sponsor

Trials
358
Recruited
74,600+
David Loew profile image

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri profile image

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

Epizyme, Inc.

Industry Sponsor

Trials
34
Recruited
2,800+

Findings from Research

Pemetrexed is an effective antifolate agent approved for treating malignant pleural mesothelioma (MPM) and metastatic non-small cell lung cancer (NSCLC), with its pharmacology and mechanism of action compared favorably to methotrexate.
Premedication with steroids and vitamin supplements can reduce the side effects of pemetrexed, making it a safer option for patients, and it should be considered a standard treatment for unresectable MPM and recurrent metastatic NSCLC.
Pemetrexed, a novel antifolate therapeutic alternative for cancer chemotherapy.Villela, LR., Stanford, BL., Shah, SR.[2015]
Pemetrexed is an effective cytotoxic agent approved for first-line treatment of non-small cell lung cancer (NSCLC) in combination with cisplatin, showing promise in phase II and III trials.
The toxicity profile of pemetrexed is comparable to other NSCLC treatments, making it a safe option for patients, and its use in postinduction maintenance therapy is currently being evaluated in a phase III study.
Pemetrexed as first-line therapy for non-squamous non-small cell lung cancer.Ricciardi, S., Tomao, S., de Marinis, F.[2021]
Serdemetan, a novel compound, shows promise as a radiosensitizer in human cancer cell lines, enhancing the effectiveness of radiation therapy, particularly in p53 wild-type cells, with sensitivity-enhancement ratios of 1.18 and 1.36 in H460 and A549 cells, respectively.
In vivo studies demonstrated that Serdemetan significantly increased tumor growth delay, with dose enhancement factors of 1.9 for H460 tumors and 1.6 for A549 tumors, indicating its potential to improve cancer treatment outcomes when used alongside radiation.
Preclinical assessment of JNJ-26854165 (Serdemetan), a novel tryptamine compound with radiosensitizing activity in vitro and in tumor xenografts.Chargari, C., Leteur, C., Angevin, E., et al.[2022]

References

Pemetrexed, a novel antifolate therapeutic alternative for cancer chemotherapy. [2015]
Pemetrexed as first-line therapy for non-squamous non-small cell lung cancer. [2021]
Preclinical assessment of JNJ-26854165 (Serdemetan), a novel tryptamine compound with radiosensitizing activity in vitro and in tumor xenografts. [2022]
Tiragolumab Impresses in Multiple Trials. [2021]
Role of pemetrexed in non-small cell lung cancer. [2022]
Phase Ia dose escalation study of OBP-801, a cyclic depsipeptide class I histone deacetylase inhibitor, in patients with advanced solid tumors. [2022]
MZ3 can induce G2/M-phase arrest and apoptosis in human leukemia cells. [2021]
Alkylating benzamides with melanoma cytotoxicity: experimental chemotherapy in a mouse melanoma model. [2013]
MZ3 induces apoptosis in human leukemia cells. [2012]
10.United Statespubmed.ncbi.nlm.nih.gov
Synthesis of benzoxazole-based vorinostat analogs and their antiproliferative activity. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Synthesis and antifolate properties of 9-alkyl-10-deazaminopterins. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
New folate analogs of the 10-deaza-aminopterin series: markedly increased antitumor activity of the 10-ethyl analog compared to the parent compound and methotrexate against some human tumor xenografts in nude mice. [2015]
13.United Statespubmed.ncbi.nlm.nih.gov
10-Ethyl-10-deaza-aminopterin: structural design and biochemical, pharmacologic, and antitumor properties. [2013]
14.United Statespubmed.ncbi.nlm.nih.gov
Adaptation of a chemosensitivity assay to accurately assess pemetrexed in ex vivo cultures of lung cancer. [2021]
Phase II trial of edatrexate in patients with advanced hepatocellular carcinoma. [2020]