Source: https://www.mycancergenome.org/content/clinical_trials/NCT02860286/
Timestamp: 2020-04-05 00:25:20
Document Index: 514517995

Matched Legal Cases: ['art 2', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2']

Clinical Trial: NCT02860286 - My Cancer Genome
https://clinicaltrials.gov/show/NCT02860286
Brief Title:Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma
Official Title:A Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With Relapsed or Refractory Malignant Mesothelioma With BAP1 Loss of Function
ORG STUDY ID: EZH-203
NCT ID: NCT02860286
BAP1 Loss of Function-
Open-Label Tazemetostat Experimental Oral Tazemetostat 800mg BID
4. Has mesothelioma (pleural, peritoneal, pericardial, tunica vaginalis) of any histology that is relapsed or refractory after treatment with at least one pemetrexed-containing regimen
5. Has a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) or equivalent laboratory certification
6. Part 2: Molecular evidence of BAP1 loss of function mutation present on local pathology, e.g., lack of nuclear BAP1 staining by immunohistochemistry (IHC) or evidence of loss of function by gene sequencing
7. Has sufficient archival tumor tissue (a minimum of 10 slides or tumor block) available for central retrospective testing of BAP1 status
8. Has all prior treatment (i.e., chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ≤ Grade 1 per CTCAE, version 4.03 or are clinically stable and not clinically significant, at time of enrollment
9. Prior therapy(ies), if applicable, must be completed according to the criteria below prior to first dose of tazemetostat:
- Non-cytotoxic chemotherapy (e.g., small molecule inhibitor); at least 14 days since last dose
- Non-antibody immunotherapy (e.g., tumor vaccine); at least 42 days since last dose
- Investigational drug; 30 days or five half-lives, whichever is longer, from last dose
10. Has measurable disease based on either modified RECIST [Nowak 2005] for thoracic disease or RECIST 1.1 elsewhere
11. Has adequate hematologic (bone marrow and coagulation factors), renal, and hepatic function as defined by criteria below:
- Coagulation: Prothrombin time (PT) <1.5 × ULN and partial thromboplastin time (PTT) <1.5 × ULN
14. Female subjects of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required and subject also should agree to use an adequate method of contraception starting with screening through 30 days after the last dose of study therapy (if sexually active).
15. Male subjects should agree to use condoms starting with the first dose of study therapy through 30 days after the last dose of study therapy if sexually active with a female of childbearing potential
3. Has had a prior malignancy other than the malignancies under study Exception: A subject who has been disease-free for 5 years, or a subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible.
4. Has had major surgery within 3 weeks prior to enrollment (a percutaneous biopsy, pleural catheter insertion, placement of central venous catheter or other minor procedure are permitted)
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 time on study
6. Has cardiovascular impairment, history of congestive heart failure greater than NYHA Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the planned first dose of tazemetostat; or ventricular cardiac arrhythmia requiring medical treatment
9. Has a congenital or acquired immunodeficiency, including subjects with known history of infection with human immunodeficiency virus (HIV) NOTE: HIV-positive subjects who are taking antiretroviral therapy are ineligible due to potential PK interactions with tazemetostat.
10. Has known history of chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (detectable anti-hepatitis C circulating viral RNA)
11. Has had a deep venous thrombosis (DVT) or pulmonary embolism within the 3 months prior to study enrollment.
Measure: Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Cmax
Measure: Part 1 and 2: Incidence of treatment-emergent adverse events as a measure of safety and tolerability
Measure: Part 1 and 2: Overall response rate (ORR; complete response + partial response [CR + PR])
Time Frame: Assessed every 6 weeks for duration of study participation which is estimated to be 12 months
Time Frame: 12 weeks and 24 weeks as the time from the date of the first dose of study treatment to the date of death due to any cause
Time Frame: 12 weeks and 24 weeks as the time from the date of the first dose of study treatment to the date of death due to any cause assessed for up to 24 months
Measure: Part 1 and 2: To evaluate the duration of response (DOR) in subjects with confirmed CR or PR
Time Frame: Every 6 weeks up to disease progression or start of new anti-cancer therapy assessed for up to 12 months
Measure: Part 1: Disease Control Rate (DCR)
Measure: Part 2: Population PK parameters: Cmax
Time Frame: Days 1 and 15 of Cycle 1, and Days 1 of Cycles 2 through 4, where each cycle is 21 days
Measure: Part 2: Population PK parameters: Tmax
Measure: Part 2: Population PK parameters: AUC(0-t)
Measure: Part 2: Population PK parameters: AUC(0-∞)
Measure: Part 2: Population PK parameters: t1/2
Measure: Part 2: Changes in H3K27me3 levels in tumor tissue as assessed by IHC
Time Frame: 6 or 12 weeks