BridgeMD
ROLLOVER STUDY FOR TAZEMETOSTAT
EU CTIS ID: 2023-510553-41-00
What this study is testing
Assess the long- term safety of tazemetostat
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1.Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
- 2.Is currently receiving or is in survival follow-up having previously received tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizymesponsored 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, treatment with other therapeutic(s) must have been completed in the antecedent study or will be provided by a source other than Epizyme if combination therapeutics are continued in this study
- 3.Has voluntarily provided signed written informed consent/assent and demonstrated willingness and ability to comply with all aspects of the protocol
- 4.Has a life expectancy of >3 months
- 5.Has adequate hematologic, (bone marrow [BM], and coagulation factors), 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. Female subjects of reproductive potential must have a negative urine/serum pregnancy test upon study entry. Female subjects who are of non-reproductive potential (ie, post- menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy) are exempt from pregnancy testing.
You likely can't join if
- 1.Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study
- 10. Has been permanently discontinued from tazemetostat therapy due to adverse event, intolerance or treatment failure.
- 2.Has an 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 v5 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 throughout their participation in the study.
See the full eligibility criteria
Who can join
- 1.Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
- 2.Is currently receiving or is in survival follow-up having previously received tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizymesponsored 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, treatment with other therapeutic(s) must have been completed in the antecedent study or will be provided by a source other than Epizyme if combination therapeutics are continued in this study
- 3.Has voluntarily provided signed written informed consent/assent and demonstrated willingness and ability to comply with all aspects of the protocol
- 4.Has a life expectancy of >3 months
- 5.Has adequate hematologic, (bone marrow [BM], and coagulation factors), 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. Female subjects of reproductive potential must have a negative urine/serum pregnancy test upon study entry. Female subjects who are of non-reproductive potential (ie, post- menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy) are exempt from pregnancy testing.
- 7. Female subjects of reproductive potential who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (eg, condoms, cervical ring, sponge, etc) during the period of therapy and for 6 months after the last dose of tazemetostat. It is recommended that barrier methods be supplemented with the use of a spermicide.
- 8. Male subjects must have had either a successful vasectomy AND remain abstinent/practice highly effective contraception and use a condom throughout the study period and for 3 months after tazemetostat discontinuation OR they and their female partner must meet the criteria above ie, not of childbearing potential.
What rules you out
- 1.Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study
- 10. Has been permanently discontinued from tazemetostat therapy due to adverse event, intolerance or treatment failure.
- 2.Has an 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 v5 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 throughout their participation in the study.
- 6.Is currently taking any prohibited medication(s) as described in Section 10.3
- 7.Is unable to take oral medications, has malabsorption syndrome, or has any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of tazemetostat
- 8.Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant bleeding diathesis or coagulopathy including known platelet function disorders, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias or psychiatric illness/social situations that would limit compliance with study requirements
- 8.Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant bleeding diathesis or coagulopathy including known platelet function disorders, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias or psychiatric illness/social situations that would limit compliance with study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.