- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874455
Tazemetostat Expanded Access Program for Adults With Solid Tumors
March 21, 2024 updated by: Epizyme, Inc.
Patients with a diagnosis listed under "conditions" below are eligible to be considered for the EAP.
These conditions must be serious or life-threatening at the time of enrollment and appropriate, comparable, or satisfactory alternative treatments must have been tried without clinical success.
Patients with conditions not listed under "conditions" below are not eligible for the tazemetostat EAP.
Study Overview
Status
No longer available
Conditions
- Renal Cell Carcinoma
- Malignant Mesothelioma
- Chondrosarcoma
- Synovial Sarcoma
- Renal Medullary Carcinoma
- Malignant Rhabdoid Tumor
- Poorly Differentiated Chordoma
- Malignant Rhabdoid Tumor of Ovary
- Epithelioid Malignant Peripheral Nerve Sheath Tumor
- Sinonasal Carcinoma
- Spindle Cell Sarcoma
- Epithelioid Sarcoma (Ex-US Only)
- Small Cell Carcinoma of the Ovary Hypercalcemic Type
- Thoracic Sarcoma
- ATRT
- Malignant Rhabdoid Tumor of Kidney
- Myxoid Spindle Cell Sarcoma
- Myoepithelial Carcinoma
- Desmoplastic Small Round Cell Tumor (DSRCT)
- Intramedullary Spinal Cord Schwannomatosis
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
- Age (at the time of consent): >18 years of age.
- They are unable to participate in tazemetostat clinical trials for their condition.
- Can provide signed written informed consent.
- Documented loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable.
Female patients of childbearing potential should:
- Agree to practice one highly effective method of contraception and one additional effective (barrier, for example condom or diaphragm with spermicide) method 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 (β-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.
Male patients with a female partner of childbearing potential should:
- Be vasectomized, or
- Agree to use condoms from first dose of tazemetostat until 30 days following the last dose of tazemetostat, or
- Have a female partner who is NOT of childbearing potential.
Exclusion Criteria:
- Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet and all foods that contain those fruits from time of enrollment to while on the EAP.
- Is currently taking any prohibited medication(s) as described in section 6.3.
- Has known hypersensitivity to any of the components of tazemetostat or other inhibitor(s) of EZH2.
- Has thrombocytopenia, neutropenia, or anemia of grade ≥3 (per CTCAE 4.03 criteria) within the past month, or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
- 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.
- Has a prior history of T-LBL/T-ALL.
- For female patients of childbearing potential: Is pregnant or nursing.
- For male patients: Is unwilling to adhere to contraception criteria from time of enrollment in study to at least 30 days after last dose of tazemetostat.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
March 12, 2019
First Submitted That Met QC Criteria
March 12, 2019
First Posted (Actual)
March 14, 2019
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neuromuscular Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Nervous System Neoplasms
- Lung Neoplasms
- Neoplasms, Complex and Mixed
- Neoplasms, Connective Tissue
- Neuroendocrine Tumors
- Adenoma
- Ovarian Neoplasms
- Peripheral Nervous System Neoplasms
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Carcinoma, Neuroendocrine
- Neoplasms, Ductal, Lobular, and Medullary
- Neoplasms, Fibrous Tissue
- Fibrosarcoma
- Neurofibroma
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Neoplasms
- Sarcoma
- Carcinoma
- Small Cell Lung Carcinoma
- Carcinoma, Ovarian Epithelial
- Rhabdoid Tumor
- Chordoma
- Carcinoma, Small Cell
- Mesothelioma
- Mesothelioma, Malignant
- Nerve Sheath Neoplasms
- Chondrosarcoma
- Neurofibrosarcoma
- Sarcoma, Synovial
- Carcinoma, Medullary
- Desmoplastic Small Round Cell Tumor
Other Study ID Numbers
- EZH-701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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