NL-OMON41336
Completed
Not Applicable
A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Relapsed/Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic Malignancies - EPZ-5676-12-001
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood cancer
- Sponsor
- Epizyme, Inc.
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female \* 18 years;2\.Dose escalation phase: Patients with histologically confirmed acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), acute mixed lineage leukemia (MLL), myelodysplastic syndrome (MDS)(IPSS Int\-2 or high\-risk), myeloproliferative disorder, or chronic myeloid Leukemia (CML) meeting the following criteria:;\*At least one prior therapy;\*Refractory disease on most recent therapy, or disease recurrence following remission on most recent therapy;\*Received and failed all known effective therapies for their disease;\*Not a candidate for allogeneic stem cell transplantation;\*In addition to the above criteria, the following disease\-specific criteria must be met:;\*AML: have received at least a standard anthracycline and cytarabinebased;induction regimen, unless not considered appropriate for aggressive induction therapy due to advanced age(\>60 years old) or a significant comorbid medical condition. Patients\>60 years old or with significant cormorbid medical conditions must have received an appropriate low\-intensity induction regimen (e.g. low\-dose cytarabine or hypomethylating agent\-based). Patients with acute promyelocytic leukemia must have also received prior retinoid and arsenic trioxidebased therapy;\*ALL: have received at least a standard anthracycline/vinca alkaloid/glucocorticoid\-based induction regimen, unless not considered appropriate for aggressive induction therapy due to advanced age (\>60 years old) or significant comorbid medical condition. Patients \>60 years old or with significant comorbid medical conditions must have received appropriate low\-intensity therapy (e.g. corticosteroid\-based therapy). Patients with Philadephia chromosome\-positive ALL must also have received prior imatinib or dasatinib.;\*CML: have received prior imatinib, dasatinib, or nilotinib (and either dasatinib or nilotinib in the event of imatinib resistance or intolerance);3\. MLL\-r/MLL\-PTD Restricted/ Expansion Phases: Patients with relapsed/refractory AML or ALL or acute MLL with rearrangement involving the MLL gene, including reciprocal chromosomal translocations involving 11q23 by FISH or cytogenetic analysis or MLL (PTD) partial tandem duplication by next generation sequencing or polymerase chain reaction and meeting the criteria below:
- •\*At least one prior therapy;\*Refractory disease on most recent therapy, or disease recurrence following remission on most recent therapy;\*Received and failed all known effective therapies for their disease;\*Not a candidate for allogeneic stem cell transplantation;\*\> 10% blasts by bone marrow aspirate or biopsy, OR biopsy documented leukemia cutis or myeloid sarcoma;\*AML: must have received at least a standard anthracycline and cytarabine\-based induction regimen, unless not considered appropriate for aggressive induction therapy due to advanced age (age\>60 years old) or a significant comorbid medical condition. Patients \>60 years old or with significant cormorbid medical conditions must have received an appropriate low\-intensity induction regimen (e.g. low\-dose cytarabine or hypomethylating agent\-based).;\*ALL: must have received at least a standard anthracycline/ vinca alkaloid/ glucocorticoid\-based induction regimen, unless not considered appropriate for aggressive induction therapy due to advanced age (\>60 years old) or significant comorbid medical condition. Patients \>60 years old or with significant comorbid medical conditions must have received appropriate low\-intensity therapy
Exclusion Criteria
- •1\. Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, significant graft\-versus\-host\-disease (GvHD) (Grade 2\-4\), symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.;2\. Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, QTc (as calculated by the Fridericia correction formula) \>470 msec, arrhythmias not controlled by medication, ejection fraction \<40% or uncontrolled congestive heart failure defined as Class II to IV per New York Heart Association Classification or patients with PR interval \>200 msec, history of underlying structural heart disease, pre\-existing AV conduction system abnormalities, cardiomyopathies or arrhythmias not controlled by medication.;3\. Receiving any other standard treatment for their hematologic malignancy, including anticancer therapies, systemic steroids, other investigational cytotoxic agents, radiation, biologic therapy or prophylactic use of hematopoietic colony stimulating factors (supportive measures will be permitted according to standards of care). Use of investigational agent(s) within 14 days or 5 half\-lives, whichever is greater, and absence of \>Grade 1 AE (except Heme) at time of study entry. ;4\. Receiving strong CYP3A4 inhibitors/ inducers.;5\. Known history of cerebrovascular accident in the past 6 months.;6\. Known bleeding diathesis.;7\. Active (symptomatic) involvement of the central nervous system (CNS) by disease. Patients considered to be at high risk of development of CNS disease may receive standard intrathecal chemotherapy prior to enrollment and continue once dosed with study drug.;8\. On immunosuppressive therapy, excluding patients with ALL receiving glucocorticoids for management of circulating blast count or patients on a stable dose (\<20mg/day prednisone or equivalent) of systemic or topical glucocorticoid therapy with \*Grade 1 GvHD.;9\. Known infection with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS). (Testing not required.);10\. Active Hepatitis B or C infection.;11\. Being actively treated for a second malignancy. However, patients on stable doses of maintenance hormonal therapy (dose unchanged for at least 2 months) for breast or prostate cancer may be enrolled into the study.;12\. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an appropriate method of contraception from at least 7 days prior to first dose of study medication administration until completion of follow\-up procedures.;13\. Male patients not willing to use a condom, plus another form of contraception (e.g., spermicide, intrauterine device (IUD), birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with females who could become pregnant. Male patients not willing to adhere to these contraceptive criteria from administration of study medication to completion of follow\-up procedures and for a total of 90 days post their last dose of experimental therapy.
Outcomes
Primary Outcomes
Not specified
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