NCT03614728 is a Phase 1, PHASE2 clinical trial of GSK3326595 in Neoplasms, sponsored by GlaxoSmithKline.

Who is sponsoring NCT03614728?

NCT03614728 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03614728?

Interventions in NCT03614728: GSK3326595, 5-Azacitidine.

Is NCT03614728 still recruiting?

NCT03614728 is currently terminated. Last updated 6 February 2023.

Are results published for NCT03614728?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-02-06 · How we verify

NCT03614728

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1, PHASE2 Results posted Last updated 6 February 2023

What this trial tests

Phase 1, PHASE2 trial testing GSK3326595 in Neoplasms in 30 participants. Terminated before completion.

Timeline

16 October 2018

Primary endpoint
11 January 2022

11 January 2022

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	16 October 2018
Primary completion	11 January 2022
Estimated completion	11 January 2022
Sites	8 locations across Canada, United States

Drugs / interventions tested

GSK3326595 — full drug profile →
5-Azacitidine — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Percentage of Participants With Clinical Benefit Rate (CBR) Primary · Up to 30.8 months

CBR is defined as the percentage of participants achieving a complete remission (CR), complete marrow remission (mCR), partial remission (PR), stable disease (SD) lasting at least 8 weeks, or hematologic improvement (HI), per International Working Group (IWG) criteria, where CR=Bone marrow:\<=5 percent(%) myeloblasts with normal maturation of all cell lines; PR=Bone marrow blasts decreased by \>=50% over pre-treatment but still \>5%; mCR=Bone marrow: \<=5% myeloblasts and decrease by \>=50% over pre-treatment; SD= Failure to achieve at least PR, but no evidence of progression \>8 weeks; HI=Ery

Group	Value	95% CI
Part 1: GSK3326595 400 mg	15	1.9 – 45.4
Part 1: GSK3326595 300 mg	18	3.8 – 43.4

Part 1: Number of Participants With Common Non-STEAEs and STEAEs Secondary · Up to 30.8 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation

Common non-STEAEs

Group	Value	95% CI
Part 1: GSK3326595 400 mg	12
Part 1: GSK3326595 300 mg	17

STEAEs

Group	Value	95% CI
Part 1: GSK3326595 400 mg	11
Part 1: GSK3326595 300 mg	12

Part 1: Number of Participants With AEs by Severity Secondary · Up to 30.8 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of each AE was reported during the study and was assigned a grade according to the NCI-CTCAE. AEs severity were graded as: Grade 1=mild; Grade 2=moderate; Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening consequences and Grade 5=death related to AE.

Grade 1

Group	Value	95% CI
Part 1: GSK3326595 400 mg	0
Part 1: GSK3326595 300 mg	0

Grade 2

Group	Value	95% CI
Part 1: GSK3326595 400 mg	1
Part 1: GSK3326595 300 mg	0

Grade 3

Group	Value	95% CI
Part 1: GSK3326595 400 mg	0
Part 1: GSK3326595 300 mg	6

Grade 4

Group	Value	95% CI
Part 1: GSK3326595 400 mg	5
Part 1: GSK3326595 300 mg	6

Grade 5

Group	Value	95% CI
Part 1: GSK3326595 400 mg	7
Part 1: GSK3326595 300 mg	5

Part 1: Number of Participants With DLTs Secondary · Up to 28 days

An event is considered to be a DLT if the event occurs within the first 28 days of treatment meeting one of the following criteria of toxicity, Hematologic: Grade 4 or greater treatment-emergent neutropenia, anemia, or thrombocytopenia, lasting for \>=14 days in the absence of Investigational Product, that cannot be attributed to underlying disease as described in NCI-CTCAE version 4; Non-hematologic: Hepatic toxicity that meets Liver Stopping Criteria, Grade 3 nausea, vomiting or diarrhea that does not improve within 72 hours despite appropriate supportive treatments, Grade 4 or greater nause

Group	Value	95% CI
Part 1: GSK3326595 400 mg	0
Part 1: GSK3326595 300 mg	0

Part 1: Overall Response Rate Secondary · Up to 30.8 months

Overall response rate is defined as the percentage of participants achieving a CR, mCR, or PR, per IWG criteria, where CR=Bone marrow: \<=5% myeloblasts with normal maturation of all cell lines; PR=Bone marrow blasts decreased by \>=50% over pre-treatment but still \>5%; mCR= Bone marrow: ≤ 5% myeloblasts and decrease by \>=50% over pre-treatment. Percentage values are rounded off.

Group	Value	95% CI
Part 1: GSK3326595 400 mg	0	0.0 – 24.7
Part 1: GSK3326595 300 mg	6	0.1 – 28.7

Part 1: Progression Free Survival Secondary · Up to 30.8 months

Progression free survival is defined as time from first dose to disease progression, as defined by IWG criteria, or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Group	Value	95% CI
Part 1: GSK3326595 400 mg	0.99	0.95 – 2.53
Part 1: GSK3326595 300 mg	0.99	0.95 – 2.43

Part 1: Overall Survival Secondary · Up to 30.8 months

Overall survival is defined as time from first dose to death due to any cause.

Group	Value	95% CI
Part 1: GSK3326595 400 mg	2.69	2.14 – 12.98
Part 1: GSK3326595 300 mg	2.96	1.28 – 15.24

Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 Following Administration of Single Dose Secondary · Day 1:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose