| Primary | Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 | 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 which results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations. | All treated Population consisted of all participants who received at least one dose of GSK3145095. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Count of Participants | | Participants | | Up to Day 95 | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. | | OG003 | Part 1-GSK3145095 400 mg BID | Participants were to receive a single 400 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 800 mg dose of GSK3145095 given as 400 mg BID | | OG004 | Part 1-GSK3145095 800 mg BID | Participants were to receive a single 800 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 1600 mg dose of GSK3145095 given as 800 mg BID. |
| | | Title | Denominators | Categories |
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| Non-serious AEs | | | | SAEs | | |
| |
| Primary | Number of Participants With Non-serious AEs and SAEs-Part 2 | 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 which results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Up to 2 years and 90 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Primary | Number of Participants With AEs by Severity Grades-Part 1 | All adverse events were analyzed using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition. Number of participants with maximum severity grades were presented. | All treated Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Count of Participants | | Participants | | Up to Day 95 | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. |
|
| Primary | Number of Participants With AEs by Severity Grades-Part 2 | All adverse events were to be analyzed using NCI-CTCAE Version 5.0. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Up to 2 years and 90 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs)-Part 1 | All toxicities were graded using NCI-CTCAE version 5.0. An AE was considered a DLT if it occurred during the first 28 days of treatment, was considered by the investigator to be clinically relevant, and met one of the following DLT criteria: hematologic toxicity: Grade 4 neutropenia, febrile neutropenia, Grade 4 anemia, Grade 3 thrombocytopenia, Grade 3 thrombocytopenia with bleeding; Grade 3 or greater non-hematologic toxicity, any Grade 2 ocular toxicity requiring systemic steroids. | All treated Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Count of Participants | | Participants | | Up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID |
|
| Primary | Number of Participants With DLTs-Part 2 | All toxicities were graded using NCI-CTCAE version 5.0. An AE was considered a DLT if it occurred during the first 28 days of treatment, was considered by the investigator to be clinically relevant, and met one of the following DLT criteria: hematologic toxicity: Grade 4 neutropenia, febrile neutropenia, Grade 4 anemia, Grade 3 thrombocytopenia, Grade 3 thrombocytopenia with bleeding; Grade 3 or greater non-hematologic toxicity, any Grade 2 ocular toxicity requiring systemic steroids. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Primary | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria-Part 3 | A participant's disease status and determination of disease progression at post Baseline visits was to be evaluated by the local investigator's assessments by RECIST version 1.1. The overall response rate (ORR)-CR and PR was to be determined by the investigator assessment of the participants computed tomography (CT) or magnetic resonance imaging (MRI) using RECIST version 1.1 criteria for target lesions. ORR is defined as the percentage of participants with a best overall confirmed CR or PR at any time as per disease-specific criteria. PR is when there is at least 30 percent decrease in sum of the longest diameter of the target lesions. Complete Response is when there is disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Until response, disease progression, initiation of another anticancer therapy or death whichever is earlier (maximum follow-up up to 2 years 90 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks. |
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| Primary | Percentage of Participants Achieving Complete Response or Partial Response Based on RECIST 1.1 Criteria-Part 4 | A participant's disease status and determination of disease progression at post Baseline visits was to be evaluated by the local investigator's assessments by RECIST version 1.1. The overall response rate (complete response and partial response) was to be determined by the investigator assessment of the participants CT or MRI using RECIST version 1.1 criteria for target lesions. ORR is defined as the percentage of participants with a best overall confirmed CR or PR at any time as per disease-specific criteria. Partial Response is when there is at least 30 percent decrease in sum of the longest diameter of the target lesions. Complete Response is when there is disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 4 was not initiated. | Posted | | | | | | Until response, disease progression, initiation of another anticancer therapy or death whichever is earlier (maximum follow-up up to 2 years and 90 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 4 GSK3145095+ Anticancer Agent | In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent. |
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| Secondary | Best Overall Response (BOR) Rate-Part 1 | Best overall response is defined as the best unconfirmed response (Complete Response [CR] > Partial Response [PR] > Stable Disease [SD] [or non-CR/non-PD] > Progressive Disease [PD] > Not Evaluable [NE]) from treatment start date until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by the investigator per RECIST version 1.1 Criteria. The BOR rate is defined as the percentage of participants with each best unconfirmed response category. Participants with unknown or missing responses were treated as non-responders, i.e., these participants were included in the denominator when calculating percentages of response. | All treated Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Number | | Percentage of participants | | Until response, disease progression, initiation of another anticancer therapy or death whichever is earlier (maximum follow-up up to 95 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. |
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| Secondary | Best Overall Response (BOR) Rate-Part 2 | Best overall response is defined as the best unconfirmed response (CR > PR > SD [or non-CR/non-PD] > PD] > NE) from treatment start date until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by the investigator per RECIST 1.1 Criteria. The BOR rate is defined as the percentage of participants with each best unconfirmed response category. Participants with unknown or missing responses were treated as non-responders, i.e., these participants were included in the denominator when calculating percentages of response. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Until response, disease progression, initiation of another anticancer therapy or death whichever is earlier (maximum follow-up up to 2 years and 90 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | Progression-free Survival (PFS)-Part 3 | PFS is defined as time from the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest. If the participant received subsequent anti-cancer therapy prior to the date of documented events, PFS was to be censored at the last adequate assessment (e.g., assessment where visit level response is confirmed response, partial response or stable disease) prior to the initiation of therapy. Otherwise, if the participant did not have a documented date of event, PFS was to be censored at the date of the last adequate assessment. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Until disease progression or death whichever is earlier (maximum follow-up up to 2 years and 90 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks. |
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| Secondary | Progression-Free Survival (PFS) -Part 4 | PFS is defined as time from the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest. If the participant received subsequent anti-cancer therapy prior to the date of documented events, PFS was to be censored at the last adequate assessment (e.g., assessment where visit level response is confirmed response, partial response or stable disease) prior to the initiation of therapy. Otherwise, if the participant did not have a documented date of event, PFS was to be censored at the date of the last adequate assessment. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 4 was not initiated. | Posted | | | | | | Until disease progression or death whichever is earlier (maximum follow-up up to 2 years and 90 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 4 GSK3145095+ Anticancer Agent | In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent. |
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| Secondary | Overall Survival -Part 3 | Overall survival is defined as time from the date of first dose to the date of death due to any cause. If a participant does not have a documented date of death, time of death is censored at the date of last contact. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Until death (maximum follow-up up to 2 years and 90 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks. |
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| Secondary | Overall Survival -Part 4 | Overall survival is defined as time from the date of first dose to the date of death due to any cause. If a participant does not have a documented date of death, time of death is censored at the date of last contact. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 4 was not initiated. | Posted | | | | | | Until death (maximum follow-up up to 2 years and 90 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 4 GSK3145095 200 mg + Anticancer Agent | In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent. |
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| Secondary | Number of Participants With Non-serious AEs and SAEs-Part 3 | 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 which results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Up to 2 years and 90 days | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks. |
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| Secondary | Number of Participants With Non-serious AEs and SAEs-Part 4 | 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 which results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 4 was not initiated. | Posted | | | | | | Up to 2 years and 90 days | | | | ID | Title | Description |
|---|
| OG000 | Part 4 GSK3145095 + Anticancer Agent | In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent. |
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| Secondary | Number of Participants With AEs by Severity Grades-Part 3 | All adverse events were planned to be analyzed using NCI-CTCAE Version 5.0. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Up to 2 years and 90 days | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks. |
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| Secondary | Number of Participants With AEs by Severity Grades-Part 4 | All adverse events were planned to be analyzed using NCI-CTCAE Version 5.0. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition. | All treated Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 4 was not initiated. | Posted | | | | | | Up to 2 years and 90 days | | | | ID | Title | Description |
|---|
| OG000 | Part 4 GSK3145095 + Anticancer Agent | In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent. |
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| Secondary | Area Under the Plasma Drug Concentration Versus Time Curve (AUC[0-t]) Following Single Dose of GSK3145095 on Day 1-Part 1 | Blood samples were collected at the indicated time points for the determination of AUC(0-t) following single dose of GSK3145095 on Day 1 and was calculated by standard non-compartmental analysis. | Pharmacokinetic (PK) Population. The PK Population consisted of all participants from the All-Treated Population for whom a PK sample was obtained and analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanograms per milliliter | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID |
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| Secondary | AUC (0-t) Following Single Dose of GSK3145095 on Day 1-Part 2 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-t) following single dose of GSK3145095 on Day 1 and was to be calculated by standard non-compartmental analysis. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Single Dose of GSK3145095 on Day 1-Part 1 | Blood samples were collected at the indicated time points for the determination of AUC (0-tau) following single dose of GSK3145095 on Day 1 and was calculated by standard non-compartmental analysis. | PK Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanograms per milliliter | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
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| Secondary | AUC (0-tau) Following Single Dose of GSK3145095 on Day 1-Part 2 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-tau) following single dose of GSK3145095. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | Maximum Observed Plasma Drug Concentration (Cmax) Following Single Dose of GSK3145095 on Day 1-Part 1 | Blood samples were collected at the indicated time points for the determination of Cmax following single dose of GSK3145095 on Day 1 and was calculated by standard non-compartmental analysis. | PK Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
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| Secondary | Cmax Following Single Dose of GSK3145095 on Day 1-Part 2 | Blood samples were to be collected at the indicated time points for the determination of Cmax following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | Minimum Observed Plasma Drug Concentration (Cmin) Following Single Dose of GSK3145095 on Day 1-Part 1 | Blood samples were collected at the indicated time points for the determination of Cmin following single dose of GSK3145095 on Day 1 and was calculated by standard non-compartmental analysis. | PK Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
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| Secondary | Cmin Following Single Dose of GSK3145095 on Day 1-Part 2 | Blood samples were to be collected at the indicated time points for the determination of Cmin following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | Time to Maximum Observed Plasma Drug Concentration (Tmax) Following Single Dose of GSK3145095 on Day 1-Part 1 | Blood samples were collected at the indicated time points for the determination of tmax following single dose of GSK3145095 on Day 1 and was calculated by standard non-compartmental analysis. | PK Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Median | Full Range | Hours | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
|
| Secondary | Tmax Following Single Dose of GSK3145095 on Day 1-Part 2 | Blood samples were to be collected at the indicated time points for the determination of tmax following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | Clearance (CL/F) Following Single Dose of GSK3145095 on Day 1-Part 1 | Blood samples were collected at the indicated time points for the determination of CL/F following single dose of GSK3145095 on Day 1 and was calculated by standard non-compartmental analysis. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
|
| Secondary | CL/F Following Single Dose of GSK3145095 on Day 1-Part 2 | Blood samples were to be collected at the indicated time points for the determination of CL/F following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | Volume of Distribution (Vz/F) Following Single Dose of GSK3145095 on Day 1-Part 1 | Blood samples were collected at the indicated time points for the determination of Vz/F following single dose of GSK3145095 on Day 1 and was calculated by standard non-compartmental analysis. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID |
|
| Secondary | Vz/F Following Single Dose of GSK3145095 on Day 1-Part 2 | Blood samples were to be collected at the indicated time points for the determination of V/F following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | Terminal Half-life (t1/2) Following Single Dose of GSK3145095 on Day 1-Part 1 | Blood samples were collected at the indicated time points for the determination of t1/2 following single dose of GSK3145095 on Day 1 and was calculated by standard non-compartmental analysis. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
|
| Secondary | T1/2 Following Single Dose of GSK3145095 on Day 1-Part 2 | Blood samples were to be collected at the indicated time points for the determination of t1/2 following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | AUC (0-t) Following Repeat Dose of GSK3145095 on Day 15-Part 1 | Blood samples were collected at the indicated time points for the determination of AUC (0-t) following repeat dose of GSK3145095 on Day 15 and was calculated by standard non-compartmental analysis. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanograms per milliliter | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
|
| Secondary | AUC (0-t) Following Repeat Dose of GSK3145095 on Day 15-Part 2 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-t) following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | AUC (0-tau) Following Repeat Dose of GSK3145095 on Day 15-Part 1 | Blood samples were collected at the indicated time points for the determination of AUC (0-tau) following repeat dose of GSK3145095 on Day 15 and was calculated by standard non-compartmental analysis. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanograms per milliliter | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
|
| Secondary | AUC (0-tau) Following Repeat Dose of GSK3145095 on Day 15-Part 2 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-tau) following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | Cmax Following Repeat Dose of GSK3145095 on Day 15-Part 1 | Blood samples were collected at the indicated time points for the determination of Cmax following repeat dose of GSK3145095 on Day 15 and was calculated by standard non-compartmental analysis. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
|
| Secondary | Cmax Following Repeat Dose of GSK3145095 on Day 15-Part 2 | Blood samples were to be collected at the indicated time points for the determination of Cmax following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | Cmin Following Repeat Dose of GSK3145095 on Day 15-Part 1 | Blood samples were collected at the indicated time points for the determination of Cmin following repeat dose of GSK3145095 on day 15 and was calculated by standard non-compartmental analysis. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
|
| Secondary | Cmin Following Repeat Dose of GSK3145095 on Day 15-Part 2 | Blood samples were to be collected at the indicated time points for the determination of Cmin following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | Tmax Following Repeat Dose of GSK3145095 on Day 15-Part 1 | Blood samples were collected at the indicated time points for the determination of tmax following repeat dose of GSK3145095 and was calculated by standard non-compartmental analysis. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Median | Full Range | Hour | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
|
| Secondary | Tmax Following Repeat Dose of GSK3145095 on Day 15-Part 2 | Blood samples were to be collected at the indicated time points for the determination of tmax following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | CL/F Following Repeat Dose of GSK3145095 on Day 15-Part 1 | Blood samples were collected at the indicated time points for the determination of CL/F following repeat dose of GSK3145095 on Day 15. For accurate estimation of CL/F following repeated administration, it is imperative that steady state has been achieved. As the attainment of steady state could not be confirmed with certainty, CL/F was not computed following repeated dose. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 |
|
| Secondary | CL/F Following Repeat Dose of GSK3145095 on Day 15-Part 2 | Blood samples were to be collected at the indicated time points for the determination of CL/F following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | Vz/F Following Repeat Dose of GSK3145095 on Day 15-Part 1 | Blood samples were collected at the indicated time points for the determination of Vz/F following repeat dose of GSK3145095 on Day 15. As t1/2 following repeated administration could not be computed, Vz/F whose estimation is dependent upon the t1/2 could not be estimated as well. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | |
|
| Secondary | Vz/F Following Repeat Dose of GSK3145095 on Day 15-Part 2 | Blood samples were to be collected at the indicated time points for the determination of V/F following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | T1/2 Following Repeat Dose of GSK3145095 on Day 15-Part 1 | Blood samples were collected at the indicated time points for the determination of t1/2 following repeat dose of GSK3145095 on Day 15. t1/2 following repeated administration was not computed because duration of observation (12 hours from the morning dose) was too short (less than 2 times the average half-life observed after the first dose) for its accurate estimation. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID |
|
| Secondary | T1/2 Following Repeat Dose of GSK3145095 on Day 15-Part 2 | Blood samples were to be collected at the indicated time points for the determination of t1/2 following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
| |
| Secondary | Dose Proportionality of GSK3145095 for Dose Levels 100 mg (50 mg BID) to 1600 mg (800 mg BID) Using AUC (0-t) Following Single Dose-Part 1 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. As only one dose level (100 mg) was tested prior to termination of the study and multiple dose levels are required to investigate dose proportionality, hence dose proportionality could not be analyzed. | PK Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Number | 95% Confidence Interval | Slope of log dose | | Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID to 800 mg BID | Participants in this arm received 100 mg as 50 mg BID dose of GSK3142095. From study Day 2 participants were to receive 200 mg as dose of 100 mg BID, 400 mg as dose of 200 mg BID, 800 mg as dose of 400 mg BID, 1600 mg as dose of 800 mg BID orally. |
| |
| Secondary | Dose Proportionality of GSK3145095 for Dose Levels 100 mg (50 mg BID) to 1600 mg (800 mg) BID Using Cmax Following Single Dose-Part 1 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. As only one dose level (100 mg) was tested prior to termination of the study and multiple dose levels are required to investigate dose proportionality, hence dose proportionality could not be analyzed. | PK Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Number | 95% Confidence Interval | Slope of log dose | | Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID to 800 mg BID | Participants in this arm received 100 mg as 50 mg BID dose of GSK3142095. From study Day 2 participants were to receive 200 mg as dose of 100 mg BID, 400 mg as dose of 200 mg BID, 800 mg as dose of 400 mg BID, 1600 mg as dose of 800 mg BID orally. |
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| Secondary | Dose Proportionality of GSK3145095 for Dose Levels 100 mg (50 mg BID) to 1600 mg (800 mg BID) Using AUC (0-tau) Following Repeat Dose-Part 1 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. As only one dose level (100 mg) was tested prior to termination of the study and multiple dose levels are required to investigate dose proportionality, hence dose proportionality could not be analyzed. | PK Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Number | 95% Confidence Interval | Slope of log dose | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID to 800 mg BID | Participants in this arm received 100 mg as 50 mg BID dose of GSK3142095. From study Day 2 participants were to receive 200 mg as dose of 100 mg BID, 400 mg as dose of 200 mg BID, 800 mg as dose of 400 mg BID, 1600 mg as dose of 800 mg BID orally. |
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| Secondary | Dose Proportionality of GSK3145095 for Dose Levels 100 mg (50 mg BID) to 1600 mg (800 mg BID) Using Cmax Following Repeat Dose-Part 1 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. As only one dose level (100 mg) was tested prior to termination of the study and multiple dose levels are required to investigate dose proportionality, hence dose proportionality could not be analyzed. | PK Population: Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Number | 95% Confidence Interval | Slope of log dose | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID to 800 mg BID | Participants in this arm received 100 mg as 50 mg BID dose of GSK3142095. From study Day 2 participants were to receive 200 mg as dose of 100 mg BID, 400 mg as dose of 200 mg BID, 800 mg as dose of 400 mg BID, 1600 mg as dose of 800 mg BID orally. |
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| Secondary | Dose Proportionality of GSK3145095 Using AUC (0-t) Following Single Dose-Part 2 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2- GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as Intravenous (IV) infusion over 30 minutes (min) for every 3 weeks. |
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| Secondary | Dose Proportionality of GSK3145095 Using Cmax Following Single Dose-Part 2 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2- GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as Intravenous (IV) infusion over 30 minutes (min) for every 3 weeks. |
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| Secondary | Dose Proportionality of GSK3145095 Using AUC (0-tau) Following Repeat Dose-Part 2 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2- GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as Intravenous (IV) infusion over 30 minutes (min) for every 3 weeks. |
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| Secondary | Dose Proportionality Using Cmax Following Repeat Dose of GSK3145095-Part 2 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 15: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2- GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as Intravenous (IV) infusion over 30 minutes (min) for every 3 weeks. |
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| Secondary | Accumulation Ratio Following Repeat Dose of GSK3145095 on Day 15-Part 1 | Accumulation ratio was calculated as AUC(0-tau) at Day 15 divided by AUC(0-tau) at Day 1 for GSK3145095. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of AUC | | Day 1: Pre-dose,0.5,1,1.5,2,3,4,6,8, 10, and 24 hour post-dose, Days 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
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| Secondary | Accumulation Ratio Following Repeat Dose of GSK3145095 on Day 15-Part 2 | Accumulation ratio was to be calculated as AUC(0-tau) at Day 15 divided by AUC(0-tau) at Day 1 for GSK3145095. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1: Pre-dose,0.5,1,1.5,2,3,4,6,8, 10, and 24 hour post-dose, Days 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | Time Invariance of GSK3145095-Part 1 | Blood samples were collected at indicated time points for analysis of time invariance. Time invariance was calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for GSK3145095. | PK Population: Only those participants with data available at the specified data points were analyzed. Study was terminated in Part-1 during first escalation cohort "GSK3145095 50 mg BID", hence subsequent escalation cohorts were not initiated. | Posted | | Median | Full Range | Ratio | | Day 1: Pre-dose,0.5,1,1.5,2,3,4,6,8,10, and 24 hour post-dose, Days 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post dose | | | | ID | Title | Description |
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| OG000 | Part 1-GSK3145095 50 mg BID | Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID). | | OG001 | Part 1-GSK3145095 100 mg BID | Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID. | | OG002 | Part 1-GSK3145095 200 mg BID | Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID. |
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| Secondary | Time Invariance of GSK3145095-Part 2 | Blood samples were to be collected at indicated time points for analysis of time invariance. Time invariance were to be calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for GSK3145095. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1: Pre-dose,0.5,1,1.5,2,3,4,6,8, 10, and 24 hour post-dose, Days 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10, and 24 hour post dose | | | | ID | Title | Description |
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| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | Plasma Concentration of Pembrolizumab -Part 2 | Blood samples were to be collected at indicated time points for the determination of plasma concentration of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | Cmax of Pembrolizumab-Part 2 | Blood samples were to be collected at indicated time points for the determination of Cmax of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | AUC (0-tau) of Pembrolizumab-Part 2 | Blood samples were to be collected at indicated time points for the determination of AUC (0-tau) of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | Cmin of Pembrolizumab-Part 2 | Blood samples were to be collected at indicated time points for the determination of Cmin of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 2 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 2-GSK3145095+ Pembrolizumab 200 mg | Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks. |
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| Secondary | AUC (0-t) Following Single Dose of GSK3145095 on Day 1-Part 3 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-t) following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | Cmax Following Single Dose of GSK3145095 on Day 1-Part 3 | Blood samples were to be collected at the indicated time points for the determination of Cmax following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | Tmax Following Single Dose of GSK3145095 on Day 1-Part 3 | Blood samples were to be collected at the indicated time points for the determination of tmax following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | T1/2 Following Single Dose of GSK3145095 on Day 1-Part 3 | Blood samples were to be collected at the indicated time points for the determination of t1/2 following single dose of GSK3145095 on Day 1. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | AUC (0-t) Following Repeat Dose of GSK3145095 on Day 15-Part 3 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-t) following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | Cmax Following Repeat Dose of GSK3145095 on Day 15-Part 3 | Blood samples were to be collected at the indicated time points for the determination of Cmax following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | Tmax Following Repeat Dose of GSK3145095 on Day 15-Part 3 | Blood samples were to be collected at the indicated time points for the determination of tmax following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | T1/2 Following Repeat Dose of GSK3145095 on Day 15-Part 3 | Blood samples were to be collected at the indicated time points for the determination of t1/2 following repeat dose of GSK3145095 on Day 15. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 15:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | AUC (0-t) Following Single Dose of Pembrolizumab-Part 3 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-t) following single dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | AUC (0-tau) Following Single Dose of Pembrolizumab -Part 3 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-tau) following single dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | Cmax Following Single Dose of Pembrolizumab -Part 3 | Blood samples were to be collected at the indicated time points for the determination of Cmax following single dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | Tmax Following Single Dose of Pembrolizumab -Part 3 | Blood samples were to be collected at the indicated time points for the determination of tmax following single dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | T1/2 Following Single Dose of Pembrolizumab -Part 3 | Blood samples were to be collected at the indicated time points for the determination of t1/2 following single dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | AUC (0-t) Following Repeat Dose of Pembrolizumab -Part 3 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-t) following repeat dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | AUC (0-tau) Following Repeat Dose of Pembrolizumab -Part 3 | Blood samples were to be collected at the indicated time points for the determination of AUC (0-tau) following repeat dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Cmax Following Repeat Dose of Pembrolizumab -Part 3 | Blood samples were to be collected at the indicated time points for the determination of Cmax following repeat dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Tmax Following Repeat Dose of Pembrolizumab -Part 3 | Blood samples were to be collected at the indicated time points for the determination of tmax following repeat dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | T1/2 Following Repeat Dose of Pembrolizumab -Part 3 | Blood samples were to be collected at the indicated time points for the determination of t1/2 following repeat dose of pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | Dose Proportionality of GSK3145095 Using AUC (0-t) Following Single Dose-Part 3 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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| Secondary | Dose Proportionality of GSK3145095 Using Cmax Following Single Dose-Part 3 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1:Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Dose Proportionality of GSK3145095 Using AUC (0-tau) Following Repeat Dose of GSK3145095-Part 3 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Dose Proportionality of GSK3145095 Using Cmax Following Repeat Dose-Part 3 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Accumulation Ratio Following Repeat Dose of GSK3145095-Part 3 | Accumulation ratio was to be calculated as AUC(0-tau) at Day 15 divided by AUC(0-tau) at Day 1 for GSK3145095. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Days 1: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post-dose; Day 15: Pre-dose,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose; Day 15: 0.5,1,2,3,6,8 hour post evening dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Time Invariance Following Repeat Dose of GSK3145095-Part 3 | Blood samples were to be collected at indicated time points for analysis of time invariance. Time invariance was to be calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for GSK3145095. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Days 1: Pre - dose ,0.5,1,1.5,2,3,4,6,8,10,24 hour; Day 15: Pre - dose ,0.5,1,1.5,2,3,4,6,8,10,24 hour post morning dose ; Day 15:0.5,1,2,3,6,8 hour post evening dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Dose Proportionality for Pembrolizumab Using AUC (0-t) Following Single Dose-Part 3 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Dose Proportionality for Pembrolizumab Using Cmax Following Single Dose-Part 3 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hour after end of infusion | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Dose Proportionality for Pembrolizumab Using AUC (0-tau) Following Repeat Dose-Part 3 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Dose Proportionality for Pembrolizumab Using Cmax Following Repeat Dose-Part 3 | Dose proportionality was to be evaluated for GSK3145095 using a fixed effects power model. Estimated slope was to be presented to express dose proportionality. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Days 8,15 (anytime during visit); Days 22,43,64 and every 21 days thereafter (pre-dose), for up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Accumulation Ratio Following Repeat Dose of Pembrolizumab-Part 3 | Accumulation ratio was to be calculated as AUC(0-tau) at Day 15 divided by AUC(0-tau) at Day 1 for pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Day 15 (anytime during visit) | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
| |
| Secondary | Time Invariance Following Repeat Dose of Pembrolizumab-Part 3 | Blood samples were to be collected at indicated timepoints for analysis of time invariance. Time invariance was to be calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for pembrolizumab. | PK Population: Data were not collected for this endpoint as study was terminated during Part 1. Subsequent Part 3 was not initiated. | Posted | | | | | | Day 1: pre-dose, 0.5 hour (within 30 minutes after end of infusion), 24 hours after end of infusion; Day 15 (anytime during visit) | | | | ID | Title | Description |
|---|
| OG000 | Part 3 GSK3145095+ Pembrolizumab 200 mg | Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks |
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