25 Participants Needed

Tazemetostat + Doxorubicin for Sarcoma

Recruiting at 20 trial locations
SD
MA
IR
IC
Overseen ByIpsen Clinical Study Enquiries
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue.Part 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study.Part 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse.The study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take medications that strongly affect a liver enzyme called CYP3A4. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is the combination of Tazemetostat and Doxorubicin safe for humans?

Doxorubicin, also known as Adriamycin, can cause heart-related side effects, such as changes in heart rhythm and heart failure, especially at higher doses. However, a drug called dexrazoxane can help protect against these heart issues. Liposomal forms of doxorubicin, like Caelyx, have been developed to reduce these toxic effects.12345

What makes the drug Tazemetostat + Doxorubicin unique for treating sarcoma?

Tazemetostat + Doxorubicin is unique because it combines a targeted therapy (Tazemetostat) with a traditional chemotherapy drug (Doxorubicin), potentially offering a novel approach to treating sarcoma by targeting specific cancer pathways while also using a well-established chemotherapy agent.16789

What data supports the effectiveness of the drug Tazemetostat + Doxorubicin for sarcoma?

Tazemetostat has been approved for treating epithelioid sarcoma, showing promise in this type of cancer. Doxorubicin is a standard treatment for soft tissue sarcomas, although its effectiveness can vary. Combining these drugs may offer a new approach, but more research is needed to confirm their combined effectiveness for sarcoma.1671011

Who Is on the Research Team?

IM

Ipsen Medical Director

Principal Investigator

Ipsen

Are You a Good Fit for This Trial?

Adults with advanced epithelioid sarcoma, a rare soft-tissue cancer, are eligible for this trial if they have measurable disease and an expected lifespan of at least 3 months. They must be able to perform daily activities with minimal assistance (ECOG status 0-2) and have proper organ function. Women can't be pregnant/breastfeeding and along with men, must use effective contraception. Those with HIV may join if well-controlled on therapy. Exclusions include active hepatitis B/C infections, other major illnesses that could interfere with the study, prior cancer treatments or conditions affecting drug absorption.

Inclusion Criteria

My blood, kidney, and liver tests meet the required levels.
I have HIV but it is well controlled with medication.
I am a man who either had a vasectomy or uses effective birth control.
See 8 more

Exclusion Criteria

I have a history of T-cell lymphoblastic lymphoma or leukemia.
I have recovered from major surgery that occurred more than 4 weeks ago.
I am not taking strong medications that affect liver enzymes or St. John's Wort.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Open-label phase to evaluate safety and establish maximum tolerated dose of tazemetostat + doxorubicin

6 cycles (21 days each)
1 visit per cycle (in-person)

Phase 3 Treatment

Double-blind phase comparing tazemetostat + doxorubicin to placebo + doxorubicin

6 cycles (21 days each) followed by continuous 28-day cycles
1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Average of two years

What Are the Treatments Tested in This Trial?

Interventions

  • Doxorubicin HCl
  • Tazemetostat
Trial Overview The trial is testing tazemetostat in combination with doxorubicin against a placebo combined with doxorubicin in patients who haven't had previous systemic anticancer therapy. Part 1 focuses on determining the safest dose level while part 2 compares how long patients live without their disease worsening using these combinations.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 1b: Open-label Tazemetostat and Phase 3: Tazemetostat + Doxorubicin ArmExperimental Treatment2 Interventions
Group II: Phase 3: Placebo + Doxorubicin ArmPlacebo Group2 Interventions

Doxorubicin HCl is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Doxorubicin for:
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Approved in United States as Doxorubicin for:
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Approved in Canada as Doxorubicin for:
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Approved in Japan as Doxorubicin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Epizyme, Inc.

Lead Sponsor

Trials
34
Recruited
2,800+

Published Research Related to This Trial

Aldoxorubicin, a prodrug of doxorubicin, shows improved progression-free survival and response rates in advanced sarcoma patients compared to doxorubicin, although it did not demonstrate an overall survival benefit in a Phase III study.
Aldoxorubicin has a favorable cardiotoxicity profile compared to doxorubicin, with no clinical cardiotoxicity observed in Phase I studies, suggesting it may be a safer option for patients at risk of heart damage.
Spotlight on aldoxorubicin (INNO-206) and its potential in the treatment of soft tissue sarcomas: evidence to date.Cranmer, LD.[2020]
In a phase II study involving 16 patients with recurrent or metastatic soft tissue sarcomas, liposomal doxorubicin (Doxil) showed no significant responses, indicating limited efficacy in this specific patient population.
Despite the lack of effectiveness, Doxil was well tolerated, with no grade 4 toxicities and only a few instances of grade 3 toxicities, suggesting a favorable safety profile for future studies in different patient groups.
A phase II study of Doxil (liposomal doxorubicin): lack of activity in poor prognosis soft tissue sarcomas.Garcia, AA., Kempf, RA., Rogers, M., et al.[2022]
Tazemetostat (Tazverik™) is the first approved treatment specifically for adults and adolescents aged 16 years and older with locally advanced or metastatic epithelioid sarcoma, receiving accelerated approval in January 2020 in the USA.
The recommended dosage is 800 mg taken orally twice daily, and Tazemetostat is also being studied for other cancers, including diffuse large B-cell lymphoma and follicular lymphoma, indicating its potential broader therapeutic applications.
Tazemetostat: First Approval.Hoy, SM.[2021]

Citations

Spotlight on aldoxorubicin (INNO-206) and its potential in the treatment of soft tissue sarcomas: evidence to date. [2020]
A phase II study of Doxil (liposomal doxorubicin): lack of activity in poor prognosis soft tissue sarcomas. [2022]
Tazemetostat: First Approval. [2021]
Aldoxorubicin for the treatment of soft tissue sarcoma. [2019]
Phase I study of non-pegylated liposomal doxorubicin in combination with ifosfamide in adult patients with metastatic soft tissue sarcomas. [2021]
Toxicologic screening of daunorubicin (NSC-82151), adriamycin (NSC-123127), and their derivatives in rats. [2016]
Protection against doxorubicin-induced cardiotoxicity in weanling rats by dexrazoxane. [2013]
The anthracyclines: will we ever find a better doxorubicin? [2022]
Effects of dexrazoxane on doxorubicin-related cardiotoxicity and second malignant neoplasms in children with osteosarcoma: a report from the Children's Oncology Group. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase II Study of Pembrolizumab in Combination with Doxorubicin in Metastatic and Unresectable Soft-Tissue Sarcoma. [2022]
Phase II trial of pegylated-liposomal doxorubicin (Doxil) in sarcoma. [2022]
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