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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04225429




Registration number
NCT04225429
Ethics application status
Date submitted
8/01/2020
Date registered
13/01/2020
Date last updated
1/10/2024

Titles & IDs
Public title
Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma
Scientific title
Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma
Secondary ID [1] 0 0
EZH-801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelioid Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Tazemetostat

Treatment: Drugs: Tazemetostat
800mg/dose taken orally twice every day.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Patients with epithelioid sarcoma (ES) are eligible to enroll in the EAP. The patient with ES must have an advanced disease that is considered life threatening at the time of enrollment and appropriate, comparable, or satisfactory alternative treatments must have been tried without clinical success. Patients with conditions other than ES are not eligible for the tazemetostat EAP.



1. Age (at the time of consent): =18 years of age.
2. They are unable to participate in tazemetostat clinical trials for their condition.
3. Can provide signed written informed consent.
4. Morphology and immunophenotypic panel consistent with epithelioid sarcoma (e.g., CD34, epithelial embrane antigen [EMA], Keratin, and INI1).
5. Female patients of childbearing potential should:

* Agree to practice one highly effective method of contraception and one additional effective barrier method (eg, condom or diaphragm with spermicide) at the same time, from the time of providing voluntary written informed consent through 30 days or 5 half-lives (whichever is longer) after the last dose of tazemetostat, and
* Have a negative beta-human chorionic gonadotropin (ß-hCG) pregnancy test at time of screening and within 14 days prior to planned first dose of tazemetostat (urine or serum test is acceptable however, positive urine tests must be confirmed with serum testing), and
* Agree to use effective contraception from start of screening until 30 days following the last dose of tazemetostat and have a male partner who uses a condom, or
* Practice true abstinence, (when this is in line with the preferred and usual lifestyle of the patient) or
* Have a male partner who is vasectomized.
6. Male patients with a female partner of childbearing potential should:

* Be vasectomized, or
* Agree to use condoms from at least 7 days prior to initiating and during tazemetostat treatment and for at least 30 days following the last dose of tazemetostat, or
* Have a female partner who is NOT of childbearing potential.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 1. Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet and all foods that contain those fruits from time of enrollment while on the EAP.

2. Is currently taking any prohibited medication(s) as described in Section 6.3 of the protocol.

3. Has known hypersensitivity to any of the components of tazemetostat or other inhibitor(s) of EZH2.

4. Has thrombocytopenia, neutropenia, or anemia of Grade =3 (per CTCAE v5.0 criteria) within the past month, or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).

5. Is known to have any abnormalities associated with MDS (e.g. del 5q, chr 7 abn) and MPN (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing.

6. Has a prior history of T-LBL/T-ALL. 7. For female patients of childbearing potential: Is pregnant or nursing. 8. For male patients: Is unwilling to adhere to contraception criteria from at least 7 days prior to initiating and during tazemetostat treatment and for at least 30 days after last dose of tazemetostat.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
NO_LONGER_AVAILABLE
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Epizyme, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04225429