Acute Myeloid Leukemia Clinical Trial

Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

Summary

This study will evaluate the safety, tolerability, and clinical activity of GSK3326595 in participants with relapsed and refractory MDS, chronic myelomonocytic leukemia (CMML), and AML. The study will be conducted in 2 parts: Part 1 will determine the clinical benefit rate (CBR) of GSK3326595 in monotherapy and Part 2 will be expanded to study GSK3326595 in combination with 5-Azacitidine which will be composed of a dose escalation phase followed by dose expansion cohort of GSK3326595.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained).
Diagnosis of MDS, CMML or AML
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
Adequate organ function
A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention.

Exclusion Criteria:

History of, or known, central nervous system (CNS) involvement
Prior solid organ transplantation
Known allergies, hypersensitivity, or intolerance to GSK3326595 or 5-Azacitidine or its excipient
Prior therapy with any Protein arginine methyl transferase 5 (PRMT5) inhibitor
History of a second malignancy, excluding non-melanoma skin cell cancer, within the last three years
Active severe or uncontrolled infection
History of optic nerve neuropathy or neuritis.
History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT03614728

Recruitment Status:

Terminated

Sponsor:

GlaxoSmithKline

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There are 8 Locations for this study

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GSK Investigational Site
Birmingham Alabama, 35294, United States
GSK Investigational Site
Miami Florida, 33136, United States
GSK Investigational Site
Boston Massachusetts, 02114, United States
GSK Investigational Site
Boston Massachusetts, 02215, United States
GSK Investigational Site
New York New York, 10065, United States
GSK Investigational Site
Houston Texas, 77030, United States
GSK Investigational Site
Milwaukee Wisconsin, 53226, United States
GSK Investigational Site
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT03614728

Recruitment Status:

Terminated

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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