Trial · NCT03614728
Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
NCT03614728, Phase 1, Phase 2, Terminated, GlaxoSmithKline; results first posted 2023-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). Trials, record NCT03614728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03614728
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
- NCT number
- NCT03614728
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms
- Interventions
- GSK3326595, 5-Azacitidine
- First posted
- 2018-08-03
- Last updated
- 2023-02-06
- Results first posted
- 2023-02-06
Source ClinicalTrials.gov
Registered outcomes58
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Percentage of Participants With Clinical Benefit Rate (CBR) | 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=Erythroid (E): hemoglobin increase of \>1.5 grams per deciliter (g/dL), HI-Platelet: increase of \>30,000/milliliter (mL) (starting with \>20,000/mL) and increase from \<20,000/mL to \>20,000/mL by \>100%; HI-Neutrophil: increase of \>100% and \>500/microliter. Percentage values are rounded off. |
| Primary | Part 2: Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment Emergent Adverse Events (STEAEs) | Up to 3 years and 2 months | An adverse event (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 serious adverse event (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. Treatment emergent adverse event (TEAE) is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with non-STEAEs and STEAEs were planned to be assessed. |
| Primary | Part 2: Number of Participants With AEs by Severity | Up to 3 years and 2 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. Number of participants with AEs by severity were planned to be assessed. |
| Primary | Part 2: Number of Participants With Dose Limiting Toxicities (DLTs) | 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 National Cancer Institute- Common Toxicity Criteria for Adverse Events (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 nausea, vomiting, or diarrhea of any duration, Any other Grade 3 or greater clinically significant non-hematologic toxicity; Other: Inability to receive all planned doses, dose interruption and Grade 2 or higher toxicity. Number of participants with DLTs were planned to be assessed. |
| Primary | Part 2: Number of Participants With AEs Leading to Dose Interruptions, Dose Reductions and Treatment Discontinuation Due to AEs | Up to 3 years and 2 months | Number of participants with AEs leading to dose interruptions, dose reductions and treatment discontinuation due to AEs were planned to be assessed. |
| Secondary | Part 1: Number of Participants With Common Non-STEAEs and STEAEs | 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 of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs which were not serious, were considered as non-STEAEs. |
| Secondary | Part 1: Number of Participants With AEs by Severity | 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. |
| Secondary | Part 1: Number of Participants With DLTs | 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 nausea, vomiting, or diarrhea of any duration, Any other Grade 3 or greater clinically significant non-hematologic toxicity; Other: Inability to receive all planned doses, dose interruption and Grade 2 or higher toxicity. |
| Secondary | Part 1: Overall Response Rate | 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. |
| Secondary | Part 1: Progression Free Survival | 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. |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 registered outcomesOutcomes58
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percentage of Participants With Clinical Benefit Rate (CBR) | Up to 30.8 months | All Treated Population consisted of all participants who received at least one dose of GSK3326595 as monotherapy or at least one dose of both combination drugs as combination treatment. | Percentage of Participants | NUMBER |
| PRIMARY | Part 2: Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment Emergent Adverse Events (STEAEs) | Up to 3 years and 2 months | All Treated Population. Data was not collected as no participants were enrolled in Part 2. | ||
| PRIMARY | Part 2: Number of Participants With AEs by Severity | Up to 3 years and 2 months | All Treated Population. Data was not collected as no participants were enrolled in Part 2. | ||
| PRIMARY | Part 2: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 28 days | DLT Evaluable Population is defined as participants who received at least 75 percent (%) of the planned doses of GSK3326595 and all seven planned doses of 5-Azacitidine (Part 2) within the 28-day DLT observation period or those who have had a DLT. Data was not collected as no participants were enrolled in Part 2. | ||
| PRIMARY | Part 2: Number of Participants With AEs Leading to Dose Interruptions, Dose Reductions and Treatment Discontinuation Due to AEs | Up to 3 years and 2 months | All Treated Population. Data was not collected as no participants were enrolled in Part 2. | ||
| SECONDARY | Part 1: Number of Participants With Common Non-STEAEs and STEAEs | Up to 30.8 months | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Number of Participants With AEs by Severity | Up to 30.8 months | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Number of Participants With DLTs | Up to 28 days | DLT Evaluable Population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Overall Response Rate | Up to 30.8 months | All Treated Population. | Percentage of Participants | NUMBER |
| SECONDARY | Part 1: Progression Free Survival | Up to 30.8 months | All Treated Population. | Months | MEDIAN |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Percentage of Participants With Clinical Benefit Rate (CBR) | Part 1: GSK3326595 400 mg | 15 | 95% Confidence Interval 1.9 to 45.4 | Percentage of Participants | |
| Part 1: Percentage of Participants With Clinical Benefit Rate (CBR) | Part 1: GSK3326595 300 mg | 18 | 95% Confidence Interval 3.8 to 43.4 | Percentage of Participants | |
| Part 1: Number of Participants With Common Non-STEAEs and STEAEs | Part 1: GSK3326595 400 mg | Common non-STEAEs | 12 | Participants | |
| Part 1: Number of Participants With Common Non-STEAEs and STEAEs | Part 1: GSK3326595 300 mg | Common non-STEAEs | 17 | Participants | |
| Part 1: Number of Participants With Common Non-STEAEs and STEAEs | Part 1: GSK3326595 400 mg | STEAEs | 11 | Participants | |
| Part 1: Number of Participants With Common Non-STEAEs and STEAEs | Part 1: GSK3326595 300 mg | STEAEs | 12 | Participants | |
| Part 1: Number of Participants With AEs by Severity | Part 1: GSK3326595 400 mg | Grade 1 | 0 | Participants | |
| Part 1: Number of Participants With AEs by Severity | Part 1: GSK3326595 300 mg | Grade 1 | 0 | Participants | |
| Part 1: Number of Participants With AEs by Severity | Part 1: GSK3326595 400 mg | Grade 2 | 1 | Participants | |
| Part 1: Number of Participants With AEs by Severity | Part 1: GSK3326595 300 mg | Grade 2 | 0 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Up to 30.8 Months) | STARTED | Part 1: GSK3326595 400 mg | 13 | |
| Part 1 (Up to 30.8 Months) | STARTED | Part 1: GSK3326595 300 mg | 17 | |
| Part 1 (Up to 30.8 Months) | STARTED | Part 2-Dose Escalation: GSK3326595+5-Azacitidine | 0 | |
| Part 1 (Up to 30.8 Months) | STARTED | Part 2-Dose Expansion: GSK3326595+5-Azacitidine | 0 | |
| Part 1 (Up to 30.8 Months) | COMPLETED | Part 1: GSK3326595 400 mg | 12 | |
| Part 1 (Up to 30.8 Months) | COMPLETED | Part 1: GSK3326595 300 mg | 16 | |
| Part 1 (Up to 30.8 Months) | COMPLETED | Part 2-Dose Escalation: GSK3326595+5-Azacitidine | 0 | |
| Part 1 (Up to 30.8 Months) | COMPLETED | Part 2-Dose Expansion: GSK3326595+5-Azacitidine | 0 | |
| Part 1 (Up to 30.8 Months) | NOT COMPLETED | Part 1: GSK3326595 400 mg | 1 | |
| Part 1 (Up to 30.8 Months) | NOT COMPLETED | Part 1: GSK3326595 300 mg | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events380
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Part 1: GSK3326595 400 mg | 6 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | Part 1: GSK3326595 300 mg | 7 | 17 | |
| other | Nausea | Gastrointestinal disorders | Part 1: GSK3326595 400 mg | 4 | 13 | |
| other | Nausea | Gastrointestinal disorders | Part 1: GSK3326595 300 mg | 5 | 17 | |
| other | Abdominal pain | Gastrointestinal disorders | Part 1: GSK3326595 400 mg | 3 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | Part 1: GSK3326595 300 mg | 2 | 17 | |
| other | Vomiting | Gastrointestinal disorders | Part 1: GSK3326595 400 mg | 3 | 13 | |
| other | Vomiting | Gastrointestinal disorders | Part 1: GSK3326595 300 mg | 2 | 17 | |
| other | Constipation | Gastrointestinal disorders | Part 1: GSK3326595 400 mg | 2 | 13 | |
| other | Constipation | Gastrointestinal disorders | Part 1: GSK3326595 300 mg | 2 | 17 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: GSK3326595 400 mg | 11 | 13 |
| Total, all-cause mortality | Part 1: GSK3326595 300 mg | 14 | 17 |
| Total, other adverse events | Part 1: GSK3326595 400 mg | 12 | 13 |
| Total, other adverse events | Part 1: GSK3326595 300 mg | 17 | 17 |
| Total, serious adverse events | Part 1: GSK3326595 400 mg | 11 | 13 |
| Total, serious adverse events | Part 1: GSK3326595 300 mg | 12 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39290981 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part 1: GSK3326595 400 mg vs Part 1: GSK3326595 300 mg: Part 1: Number of Participants With DLTs | Trial comparisons |
| Part 1: GSK3326595 400 mg vs Part 1: GSK3326595 300 mg: deaths from any cause | Trial comparisons |
| Part 1: GSK3326595 400 mg vs Part 1: GSK3326595 300 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03614728
GET https://conductscience.org/api/trials/v1/NCT03614728/registered?page=2