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Tazemetostat for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Endometrial Cancer+4 MoreTazemetostat - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial looks at how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back.

Eligible Conditions
  • Recurrent Ovarian Clear Cell Carcinoma
  • Endometrial Cancer
  • Recurrent Ovarian Endometrioid Adenocarcinoma
  • Recurrent Ovarian Cancer
  • Recurrent Endometrial Endometrioid Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
LY3819253
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MT-101

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 5 years

Year 5
Overall survival
Year 5
Progression-free survival
Up to 5 years
Incidence of adverse events
Up to 6 months
6-month progression free survival (clinical benefit rate)
ARID1A mutational status
BAF250a expression
Tumor response
Tumor response in patients with ARID1A mutations using tumor response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
L-Arginine
2
LY3819253
1
MT-101

Side Effects for

Participants With Diffuse Large B-cell Lymphoma
33%Oesophageal carcinoma
33%Supraventricular tachycardia
33%Fatigue
33%Alopecia
33%Nasopharyngitis
33%Arthralgia
33%Non-cardiac chest pain
33%Dysgeusia
33%Hypertension
33%Back pain
33%Hypochromic anaemia
33%Conjunctival haemorrhage
33%Electrocardiogram QT prolonged
33%Dizziness
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03456726) in the Participants With Diffuse Large B-cell Lymphoma ARM group. Side effects include: Oesophageal carcinoma with 33%, Supraventricular tachycardia with 33%, Fatigue with 33%, Alopecia with 33%, Nasopharyngitis with 33%.

Trial Design

1 Treatment Group

Treatment (tazemetostat)
1 of 1

Experimental Treatment

86 Total Participants · 1 Treatment Group

Primary Treatment: Tazemetostat · No Placebo Group · Phase 2

Treatment (tazemetostat)Experimental Group · 2 Interventions: Laboratory Biomarker Analysis, Tazemetostat · Intervention Types: Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,068 Previous Clinical Trials
41,129,216 Total Patients Enrolled
70 Trials studying Endometrial Cancer
70,467 Patients Enrolled for Endometrial Cancer
NRG OncologyOTHER
217 Previous Clinical Trials
94,042 Total Patients Enrolled
2 Trials studying Endometrial Cancer
395 Patients Enrolled for Endometrial Cancer
Ramez N EskanderPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
810 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with recurrent or persistent OCCC with ARID1A pathologic variant or likely pathologic variant mutations per next generation sequencing (NGS) are eligible for entry (20-OCT-2021).
You have had at least one, but no more than three prior cytotoxic regimens for management of primary disease; unlimited prior hormonal therapy, targeted therapy (including immunotherapy) or antiangiogenic therapy will be permitted.
You have not received chemotherapy for more than 28 days prior to registration.
You have received chemotherapy using nitrosoureas.
A diagnosis of ovarian cancer must be made based on the histopathology report of the primary tumor or the recurrent tumor if available
You have received at least 6 weeks of chemotherapy since last dose of chemotherapy.
References

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