Clinical trial NCT02875548: A Study to Assess Long-term Safety of Tazemetostat in Adult Participants of All Ages With Any Disease Treated With Tazemetostat in a Previous Clinical Study
Official title: Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Diffuse Large B-cell Lymphoma (DLBCL)
Follicular Lymphoma (FL)
Synovial Sarcoma
Epitheliod Sarcoma (ES)
Mesothelioma
Advanced Solid Tumors
Renal Medullary Carcinoma
Non-Hodgkin Lymphoma (NHL)
Keywords: Epizyme
Tazverik
Tazemetostat (EPZ-6438)
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-08-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy.

The aim of the study will be to assess the long-term safety of tezemetostat.

Detailed description: This open-label, multicenter, global study will provide continuing access to tazemetostat therapy for subjects who have completed their participation in a prior tazemetostat study (either with monotherapy or combination therapy)

without unacceptable toxicity, have not had evidence of tumor progression as defined by disease-appropriate standard criteria, and continue to receive clinical benefit from the therapy.

Subjects will receive tazemetostat as dictated in their antecedent study. Visits will be conducted per Standard of Care (SoC) as appropriate in each country and as determined by the Investigator. Subjects will be followed for long-term safety in addition to time to treatment failure (TTF) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

1. Subjects must meet ALL criteria to be eligible for enrollment in this study.
2. Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
3. 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, 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 until disease progression, treatment toxicity, subject preference or death, up to approximately 7 years.
4. Has voluntarily provided signed written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
5. Has a life expectancy of ≥3 months.
6. 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

Exclusion Criteria:

Subjects meeting ANY of the following criteria must NOT be enrolled in this study:

1. Has had an interruption of tazemetostat dosing of \>14 days from the antecedent clinical study to starting the rollover study unless approved by the Medical Monitor.
2. Has another 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.

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs)
timeFrame: Until end of study an average of 7 years
measure: Duration of Study Drug Exposure
timeFrame: Until end of study an average of 7 years
Secondary outcomes:
measure: The overall survival (OS)
timeFrame: Until end of study an average of 7 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Santa Fe
country: United States
facility: California Cancer Associates For Research And Excellence, cCARE
state: California
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast - Port St. Lucie
state: Florida
city: Tampa
country: United States
facility: Moffitt
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Bolivar
country: United States
facility: Central Care Cancer Center
state: Missouri
city: East Brunswick
country: United States
facility: Astera Cancer Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: David H. Koch Center for Cancer Care at memorial Sloan Kettering Cancer Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
state: Pennsylvania
city: Alexandra
country: Australia
facility: Princess Alexandra Hospital
city: Clayton
country: Australia
facility: Monash Medical Centre- Monash Campus
city: Geelong
country: Australia
facility: Geelong Hospital
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute
city: Monash
country: Australia
facility: Monash Health
city: Leuven
country: Belgium
facility: University Hospital (UZ) Leuven
city: Bordeaux Cedex
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: CHU de Caen - Hôpital Côte de Nacre
city: Lille Cedex
country: France
facility: CHRU de Lile- Hopital Claude Huriez
city: Montpellier
country: France
facility: CHU de Montpellier - Hopital Saint Eloi
city: Paris
country: France
facility: Hôpital Saint Louis - AP-HP
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes Cedex
country: France
facility: CHU Rennes- Hopital Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Villejuif
country: France
facility: Gustave Roussay
city: Kraków
country: Poland
facility: Pratia MCM Krakow
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej
city: Kharkiv
country: Ukraine
facility: S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"
city: Glasgow
country: United Kingdom
facility: Beatson, West of Scotland Cancer Centre
city: Leicester
country: United Kingdom
facility: Oncology and Haematology Clinical Trials Unit
city: Liverpool
country: United Kingdom
facility: Clatterbridge Cancer Centre
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: