Tazemetostat Rollover Study (TRuST): An Open-Label Rollover Study
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Cancer, Cancer, Cancer, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/12/2019 |
Start Date: | August 2016 |
End Date: | April 2024 |
Contact: | Epizyme |
Email: | clinicaltrials@epizyme.com |
Phone: | 855-500-1011 |
This study will provide continuing availability to tazemetostat as a single agent to subjects
who have completed their participation in an antecedent tazemetostat study (either with
monotherapy or combination therapy). In addition, long-term safety and overall survival will
be collected.
who have completed their participation in an antecedent tazemetostat study (either with
monotherapy or combination therapy). In addition, long-term safety and overall survival will
be collected.
Inclusion Criteria:
1. Has demonstrated clinical benefit from treatment with tazemetostat.
2. Is currently receiving tazemetostat as either monotherapy or in combination with other
approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical trial or
any other clinical trial being conducted with tazemetostat that is not sponsored by
Epizyme (including but not limited to, Investigator initiated trials). For subjects on
combination therapy, the other therapeutic(s) must have been completed or will be
provided by a source other than Epizyme
3. Has provided signed written informed consent
4. Has a life expectancy of >3 months
5. Has adequate hematopoietic, coagulation, renal and hepatic function. Subject must
remain eligible for continued treatment with tazemetostat according to the eligibility
and treatment criteria from the antecedent study.
6. For French subjects only: Is either affiliated with or a beneficiary of a social
security category.
7. Female subjects of childbearing potential must:
- Have a negative beta-human chorionic gonadotropin (β-hCG) pregnancy test at time
of study entry and within 14 days prior to planned first dose of investigational
product, and
- Agree to use effective contraception until 30 days following the last dose of
investigational product and have a male partner who uses a condom or
- Practice true abstinence or
- Have a male partner who is vasectomized.
8. Male subjects with a female partner of childbearing potential must:
- Be vasectomized, or
- Agree to use condoms until 30 days following the last dose of investigational
product, or
- Have a female partner who is NOT of childbearing potential.
Exclusion Criteria:
1. Has had an interruption of tazemetostat dosing of >14 days from the antecedent
clinical study to starting the rollover study unless approved by Medical Monitor.
2. Has any other malignancy other than the one for which they are receiving tazemetostat
Exception: Subject who has been disease-free of a prior malignancy for 5 years, or
subject with a history of a completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma is eligible.
3. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 4.03 criteria) or
any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
4. Has a prior history of T-LBL/T-ALL.
5. 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 study.
6. Is currently taking any prohibited medication(s).
7. Is unable to take oral medications, malabsorption syndrome or any other uncontrolled
gastrointestinal condition (e.g., nausea, diarrhea or vomiting) that might impair the
bioavailability of tazemetostat
8. Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled
infection, or psychiatric illness/social situations that would limit compliance with
study requirements.
9. For female subjects of childbearing potential: Is pregnant or nursing
10. Has been permanently discontinued from tazemetostat therapy due to adverse event,
intolerance or treatment failure
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