Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma
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Diakoneo Diak Schwaebisch Hall gGmbH 74523 Schwäbisch Hall (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Thomas Geer, MD» Ansprechpartner anzeigenKlinikum Der Universität München AöR 81377 München (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Dreyling Martin, MD» Ansprechpartner anzeigenKlinikum rechts der Isar der Technischen Universitat Muenche 81675 München (Bayern) GermanyZurückgezogen» Google-Maps
Darmkrebszentrum der Universitätsmedizin Mainz Langenbeckstraße 1 55131 Mainz DeutschlandRekrutierend» Google-Maps Ansprechpartner: Georg Hess, MD» Ansprechpartner anzeigenUniversitaetsklinikum Bonn AöR 53127 Bonn (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Franz-Georg Bauernfeind, MD» Ansprechpartner anzeigenDarmzentrum der Kliniken Maria Hilf GmbH Mönchengladbach Sandradstraße 43 41061 Mönchengladbach DeutschlandRekrutierend» Google-Maps Ansprechpartner: Ullrich Graeven, MD» Ansprechpartner anzeigenStädt. 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1. Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2) (Time Frame - Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 will be selected at the end of Phase 1b): The safety and tolerability of tazemetostat in combination with R2 in subjects with R/R FL will be evaluated. RP3D of tazemetostat for further evaluation in phase 3 will be selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).
2. Progression-free Survival (PFS) (Time Frame - Up to 72 months): PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.
Secondary outcome:
1. Pharmacokinetics (PK) of tazemetostat: Maximum (peak) Observed Plasma Drug Concentration (Cmax). (Time Frame - In cycles 1 and 2 on days 1 and 15 (28 days cycle)): Cmax will be recorded from the PK blood samples collected.
2. PK of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit: Time to Maximum Observed Drug Concentration (Tmax) (Time Frame - In cycles 1 and 2 on days 1 and 15 (28 days cycle))
3. PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration [AUC(0-t)], (Time Frame - In cycles 1 and 2 on days 1 and 15 (28 days cycle))
4. PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to infinity [AUC(0-∞)] (Time Frame - In cycles 1 and 2 on days 1 and 15 (28 days cycle))
5. The apparent terminal elimination half-life (t1/2) of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit (Time Frame - In cycles 1 and 2 on days 1 and 15 (28 days cycle))
6. PFS (Time Frame - Up to 72 months): PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by blinded independent review committee (IRC).
7. Objective Response Rate (ORR) (Time Frame - Up to 72 months): ORR is defined as the proportion of subjects achieving partial response (PR) or complete response (CR) according to the 2014 Lugano Classification as assessed by Investigator and IRC.
8. Duration of response (DOR) (Time Frame - Up to 72 months): DOR is defined as the time from initial CR or PR to documented progression or death, whichever occurs first, as assessed by Investigator and IRC.
9. Duration of complete response (DOCR) (Time Frame - Up to 72 months): DOCR, defined as the time from initial CR to documented progression or death, whichever occurs first, as assessed by Investigator and IRC.
10. Disease control rate (DCR) (Time Frame - Up to 72 months): Disease control rate defined as the proportion of subjects with best overall response of CR, PR, or SD lasting 12 or more months, as assessed by the Investigators and IRC.
11. Quality of life questionnaires evaluation (Time Frame - Measured at Screening, on Day 1 and Day 15 of Cycles 1 and 2, on Day 1 and optionally on Day 15 of each cycle from Cycle 3 and beyond, and at end of treatment visit, up to 3 years. (Each cycle is 28 days)): Evaluate and compare health-related quality of life as measured by the EuroQOL 5-Dimension 5-Level (EQ-5D-5L) instrument and the Functional Assessment of Cancer Therapy -Lymphoma (FACT-Lym)
12. Overall Survival (OS) (Time Frame - up to 100 weeks): OS is defined as the time from the date of randomization until death due to any cause.
13. Population PK parameters of oral clearance (CL/F) of tazemetostat (Time Frame - Up to 72 months): CL/F will be used to generate estimates of tazemetostat AUC
14. Population PK parameters of oral volume of distribution (Vd/F) of tazemetostat. (Time Frame - Up to 72 months)
15. Population PK parameters of first-order absorption rate constant (Ka) for tazemetostat. (Time Frame - Up to 72 months)
16. Percentage of Participants Experiencing Adverse Events (AEs) (Time Frame - Up to 72 months): An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
17. Percentage of Participants with Clinically Significant Changes in Physical Examination (Time Frame - Up to 72 months): Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
18. Percentage of Participants with Clinically Significant Changes in Vital Signs (Time Frame - Up to 72 months): Percentage of participants with clinically significant changes in vital signs findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
19. Percentage of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Readings (Time Frame - Up to 72 months): Percentage of participants with clinically significant changes in ECG Readings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
20. Performance status evaluated by Eastern Cooperation Oncology Group (ECOG) (Time Frame - Up to 72 months): ECOG is a 6-point performance status scale used to assess performance using PA as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 5 = dead) Performance status will be assessed per usual clinical practice and will be recorded in the medical record.
21. Duration of Study Drug Exposure (Time Frame - Up to 72 months): Duration of exposure to study drug will be reported.
22. Total Number of Treatment Cycles (Time Frame - Up to 72 months): Total number of treatment cycles for the study drug will be reported.
23. Percentage of Study Drug Taken by Participants (Time Frame - Up to 72 months)
24. Average Dose Intensity of Study Drug (Time Frame - Up to 72 months): The average dose intensity per participant = total dose (mg) per participant / duration of treatment (days).
25. Number of Participants Requiring Dose Reductions, Treatment Interruption or Treatment Discontinuation (Time Frame - Up to 72 months)
Experimental: Tazemetostat + R2 arm Stage 1 (Phase 1b):
Tazemetostat will be escalated from a starting dose of 400 mg PO twice daily to 600 mg PO twice daily to 800 mg PO twice daily in 28-day cycles.
Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.
Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or <60 mL/minute), administred PO QD on days 1 to 21 for 12 cycles.
Stage 2 and Optional Stage 3 (Phase 3):
Tazemetostat 800 mg administered PO twice daily in continuous 28-day cycles.
Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.
Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or <60 mL/minute), PO QD on days 1 to 21 for 12 cycles.
Maintenance Therapy (Stage 1, 2, and Optional Stage 3):
Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Placebo Comparator: Placebo + R2 Arm Stage 2 and Optional Stage 3 (Phase 3):
Placebo administered PO twice daily in continuous 28-day cycles.
Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.
Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or <60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.
Maintenance Therapy (Stage 1, 2, and Optional Stage 3):
Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. During maintenance, placebo will be continued until disease progression or unacceptable toxicity, or participant withdraws consent.
Tazemetostat (EPZ-6438 / IPN60200 / ): Stage 1 (Phase 1b):
Tazemetostat will be escalated from a starting dose of 400 mg orally twice daily to 600 mg orally twice daily to 800 mg PO twice daily in 28-day cycles as tolerated in a standard 3 + 3 design. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Tazemetostat (EPZ-6438 / IPN60200 / ): Stage 2 and Optional Stage 3 (Phase 3):
Tazemetostat 800 mg administered orally twice daily in continuous 28-day cycles for 12 cycles. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Placebo oral tablet: Placebo administered orally twice daily in continuous 28-day cycles. Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Lenalidomide: Lenalidomide 20 mg capsules or 10 mg capsules (if creatinine clearance ≥60 mL/minute or <60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.
Rituximab: Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.
Quelle: ClinicalTrials.gov
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"Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma"
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