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

NCT ID: NCT03614728

Last Updated: 2023-02-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2022-01-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

This is an open-label, multicenter, multi-part study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Participants receiving GSK3326595

Group Type EXPERIMENTAL

GSK3326595

Intervention Type DRUG

GSK3326595 will be administered.

Part 2 Dose escalation : Participants receiving GSK3326595+5-Azacitidine

Group Type EXPERIMENTAL

GSK3326595

Intervention Type DRUG

GSK3326595 will be administered.

5-Azacitidine

Intervention Type DRUG

5-Azacitidine will be administered.

Part 2 Dose expansion: Participants receiving GSK3326595+5-Azacitidine

Group Type EXPERIMENTAL

GSK3326595

Intervention Type DRUG

GSK3326595 will be administered.

5-Azacitidine

Intervention Type DRUG

5-Azacitidine will be administered.

Interventions

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GSK3326595

GSK3326595 will be administered.

Intervention Type DRUG

5-Azacitidine

5-Azacitidine will be administered.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Milwaukee, Wisconsin, United States

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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Watts J, Minden MD, Bachiashvili K, Brunner AM, Abedin S, Crossman T, Zajac M, Moroz V, Egger JL, Tarkar A, Kremer BE, Barbash O, Borthakur G. Phase I/II study of the clinical activity and safety of GSK3326595 in patients with myeloid neoplasms. Ther Adv Hematol. 2024 Sep 14;15:20406207241275376. doi: 10.1177/20406207241275376. eCollection 2024.

Reference Type DERIVED
PMID: 39290981 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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208809

Identifier Type: -

Identifier Source: org_study_id

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