| Primary | Part 1: Number of Participants With Treatment-emergent (TE) Adverse Events (AEs) and TE Serious AEs (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. | Safety Population included all participants who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Up to 11.3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. | | OG003 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. | | OG004 | Part 1: GSK3745417 200 ug | Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection. | | OG005 | Part 1: GSK3745417 300 ug | Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection. |
| | | Title | Denominators | Categories |
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| TEAEs | | |
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| Primary | Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades | AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0): Grade(G) 1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE. | | Posted | | Count of Participants | | Participants | | Up to 11.3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. |
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| Primary | Part 1: Number of Participants With Dose Limiting Toxicities (DLT) | An AE is considered to be a DLT if it is considered by the investigator to be clinically relevant and attributed (definitely, probably, or possibly) to the study intervention and meets at least 1 of the criteria listed below. Criteria for DLT included Grade(G)3 or 4 Cytokine Release Syndrome (CRS); G3 or 4 tumor lysis syndrome (TLS) that cannot be managed/ is not resolved within 72 hours (h); Liver Toxicity included Alanine aminotransferase (ALT)>=3* upper limit of normal (ULN), plus bilirubin>=2* ULN (>35 percent [%] direct) or plus international normalized ratio (INR)>1.5 (Possible Hy's law); G>=3 non-hematologic toxicity of any duration; G>=3 immune-related toxicity that does not resolve to G<=1 or Baseline within 8 days despite adequate immune suppressive therapy. Any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT. | DLT-evaluable Population included all participants who took at least 1 dose of study intervention and followed for the DLT observation period or were withdrawn within the DLT observation period due to meeting the DLT criteria. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | |
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| Primary | Part 1: Number of Participants With Withdrawals Due to AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. | | Posted | | Count of Participants | | Participants | | Up to 11.3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. | | OG003 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. |
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| Primary | Part 2: Objective Response Rate (ORR) | Overall response rate (ORR) defined as the percentage of participants with a complete remission (CR), CR with incomplete platelet recovery (CRp), incomplete count recovery (CRi), or a partial remission (PR) as per response criteria for AML and HR-MDS. CR=The participant must achieve a morphologic leukemia-free state (<= 5% blasts) and have no evidence of extramedullary disease. The participant must be free of all symptoms related to leukemia, have an absolute neutrophil count >= 1*10^9/Liter (L) and platelet count >=100*10^9/L, and be transfusion independent. CRp: Marrow response as per CR but platelet count <100 × 10^9/L. CRi: Marrow response as per CR but platelet count <100*10^9/L or neutrophil count <1*10^9/L. PR=A decrease from Baseline of at least 50% in the number of bone marrow blasts, to between 5% and 25% of the bone marrow aspirate. | Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Up to Day 84 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Primary | Part 2: Number of Participants With TEAEs and TESAEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. | Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Up to 49 weeks | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Primary | Part 2: Number of Participants With TEAEs and TESAEs by Severity Grades | AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE (version 5.0): G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE. | Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Up to 49 weeks | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Primary | Part 2: Number of Participants With Dose Limiting Toxicities (DLT) | An AE is considered to be a DLT if it is considered by the investigator to be clinically relevant and attributed (definitely, probably, or possibly) to the study intervention and meets at least 1 of the criteria listed below. Criteria for DLT included Grade(G)3 or 4 Cytokine Release Syndrome (CRS); G3 or 4 TLS that cannot be managed/ is not resolved within 72 hours (h); Liver Toxicity included ALT>=3*upper limit of normal (ULN), plus bilirubin>=2*ULN (>35% direct) or plus international normalized ratio (INR)>1.5 (Possible Hy's law); G>=3 non-hematologic toxicity of any duration; G>=3 immune-related toxicity that does not resolve to G<=1 or Baseline within 8 days despite adequate immune suppressive therapy. Any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT. | Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Primary | Part 2: Number of Participants With Withdrawals Due to AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. | Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Up to 49 weeks | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Secondary | Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 12.5 µg, 25 ug, 50 µg and 200 µg | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3745417. | Pharmacokinetic (PK) Population included all participants from the Safety Analysis Set for whom a PK sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter (ng/mL) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 100 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter (ng/mL) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 300 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter (ng/mL) | | Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 300 ug | Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter (h*ng/mL) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 100 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter (h*ng/mL) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. |
| |
| Secondary | Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 300 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter (h*ng/mL) | | Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 300 ug | Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection. |
| |
| Secondary | Part 1: AUC (0-tau) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter (h*ng/mL) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. |
|
| Secondary | Part 1: AUC (0-tau) Following Administration of GSK3745417 100 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter (h*ng/mL) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. |
| |
| Secondary | Part 1: AUC (0-tau) Following Administration of GSK3745417 300 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter (h*ng/mL) | | Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 300 ug | Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection. |
| |
| Secondary | Part 1: AUC(0-infinity) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter (h*ng/mL) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. |
|
| Secondary | Part 1: AUC(0-infinity) Following Administration of GSK3745417 100 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter (h*ng/mL) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: AUC(0-infinity) Following Administration of GSK3745417 300 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter (h*ng/mL) | | Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 300 ug | Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection. |
| |
| Secondary | Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/hour | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. |
|
| Secondary | Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 100 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/hour | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. |
| |
| Secondary | Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 300 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/hour | | Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 300 ug | Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection. |
| |
| Secondary | Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour (h) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. |
|
| Secondary | Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 100 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour (h) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. |
| |
| Secondary | Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 300 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour (h) | | Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3745417 300 ug | Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5 | | | | ID | Title | Description |
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| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 100 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 300 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | | Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8 | | | | ID | Title | Description |
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| OG000 | Part 1: GSK3745417 300 ug | Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Volume of Distribution (V) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5 | | | | ID | Title | Description |
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| OG000 | Part 1: GSK3745417 12.5 ug | Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection. | | OG001 | Part 1: GSK3745417 25 ug | Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection. | | OG002 | Part 1: GSK3745417 50 ug | Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Volume of Distribution (V) Following Administration of GSK3745417 100 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 1: GSK3745417 100 ug | Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 1: Volume of Distribution (V) Following Administration of GSK3745417 300 µg | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8 | | | | ID | Title | Description |
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| OG000 | Part 1: GSK3745417 300 ug | Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection. |
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| Secondary | Part 2: Number of Participants With AEs, SAEs and Adverse Events of Special Interest (AESIs) Leading to Dose Modification and Dose Delays | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. AESI includes events that were immune-related or related to Cytokine Release Syndrome or tumor lysis syndrome. | Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Up to 49 weeks | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Secondary | Part 2: Cmax Following Administration of GSK3745417 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Secondary | Part 2: AUC(0-t) Following Administration of GSK3745417 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Secondary | Part 2: AUC(0-tau) Following Administration of GSK3745417 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Secondary | Part 2: AUC(0-infinity) Following Administration of GSK3745417 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Secondary | Part 2: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Secondary | Part 2: Terminal Phase Half-life (t1/2) Following Administration of Single Dose GSK3745417 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Secondary | Part 2: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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| Secondary | Part 2: Volume of Distribution (V) Following Administration of GSK3745417 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417. | Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study. | Posted | | | | | | Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3745417 | Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study. |
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