May 9, 2017
|
May 11, 2017
|
July 29, 2021
|
August 26, 2021
|
August 10, 2022
|
July 18, 2017
|
July 31, 2020 (Final data collection date for primary outcome measure)
|
- Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 21.3 months ]
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function.
- Number of Participants With AEs Leading to Any Dose Reduction or Delays [ Time Frame: Up to 21.3 months ]
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to any dose reduction or delays have been presented.
- Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment [ Time Frame: Up to 21.3 months ]
Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs have been presented.
- Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50) [ Time Frame: Up to 21.3 months ]
PSA50 response rate is defined as percentage of participants with a decrease of >=50% in the PSA concentration from the Baseline PSA value determined at least 12 weeks after start of treatment and confirmed >=4 weeks later by an additional PSA evaluation.
|
- Number of subjects with adverse events (AE) and serious adverse events (SAE) [ Time Frame: Approximately up to 3 years ]
Any AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.
- Number of subjects with dose reductions or delays [ Time Frame: Approximately up to 3 years ]
Dose reductions or delays will be evaluated during the treatment period.
- Number of subjects withdrawn due to toxicity [ Time Frame: Approximately up to 3 years ]
Withdrawals will be collected during the study period until the end of study.
- Number of subjects with abnormality in laboratory parameters [ Time Frame: Approximately up to 3 years ]
Laboratory parameters includes clinical chemistry, hematology parameters, liver function tests, routine urinalysis and cardiac studies
- Number of subjects with abnormality in vital signs [ Time Frame: Approximately up to 3 years ]
Vital signs to be measured in semi-supine position after 5 minutes rest will include temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate.
- Number of subjects with abnormality in electrocardiogram (ECG) [ Time Frame: Approximately up to 3 years ]
Triplicate 12-lead ECGs will be obtained, prior to dosing at specific time periods
- Number of subjects with abnormality in any cardiotoxicity parameters [ Time Frame: Approximately up to 3 years ]
Echocardiography (ECHO) or multigated acquisition (MUGA) scan will be performed to assess cardiotoxicity
- Number of subjects with abnormality in gastrointestinal parameters [ Time Frame: Approximately up to 3 years ]
Gastrointestinal effects will be assessed during the treatment period.
- Percentage of subjects with Prostate Specific Antigen 50 (PSA50) [ Time Frame: At 12 weeks and there after (assessed up to maximum of 3 years) ]
PSA50 is ≥50% decrease in PSA from baseline. It will be analyzed after 12 weeks of treatment
|
|
- Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246 [ Time Frame: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 ]
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. PK Population consisted of all participants from the All Treated Safety Population for whom a PK sample was obtained and analyzed.
- Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246 [ Time Frame: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 ]
Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.
- Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246 [ Time Frame: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 ]
Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.
- Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246 [ Time Frame: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 ]
Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.
- Cmax of Abiraterone [ Time Frame: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 ]
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.
- Tmax of Abiraterone [ Time Frame: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 ]
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.
- AUC(0-tau) of Abiraterone [ Time Frame: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 ]
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.
- Ctrough of Abiraterone [ Time Frame: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 ]
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.
- Cmax of Enzalutamide [ Time Frame: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25 ]
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis.
- Tmax of Enzalutamide [ Time Frame: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25 ]
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis.
- AUC(0-tau) of Enzalutamide [ Time Frame: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25 ]
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis.
- Ctrough of Enzalutamide [ Time Frame: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25 ]
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis.
- Disease Control Rate at Week 24 [ Time Frame: Week 24 ]
Disease control rate (DCR) is defined as the percentage of participants with >=1 post-Baseline disease assessment who showed either a confirmed complete response (CR), partial response (PR) or stable disease (SD) observed at >=24 weeks per prostate cancer working group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; where CR: disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter in the short axis; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive diseases. Confidence interval (CI) was computed using exact two sided 95% CI.
- Composite Response Rate [ Time Frame: Up to 21.3 months ]
Composite response rate was defined as the percentage of participants with one of the following: a) Response based on PCWG3-modified RECIST version 1.1, b) PSA decrease of >=50% from Baseline at Week 12 and thereafter, or c) Circulating Tumor-cell Count Conversion from unfavorable (>=5/7.5 milliliter [mL]) at Baseline to favorable (<5/7.5 mL) confirmed by a second assessment at least 4 weeks later. If a participant met at least one of the above requirements, then that participant was considered a composite responder. CI was computed using exact two sided 95% CI.
- Objective Response Rate [ Time Frame: Up to 21.3 months ]
Objective response rate (ORR) is defined as the percentage of participants with a confirmed CR or PR at any time as per PCWG3-modified RECIST version 1.1; where CR: Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis and PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
- Circulating Tumor Cells (CTC) Response Rate [ Time Frame: Up to 21.3 months ]
CTC response rate is defined as the percentage of participants with a CTC conversion to <5/7.5 mL blood at nadir (confirmed by a second consecutive value obtained four or more weeks later) for participants with unfavourable CTC (>=5/7.5 mL) at Baseline. CI was computed using exact two sided 95% CI.
- Prostate-specific Antigen (PSA) Response Rate at Week 4 [ Time Frame: Week 4 ]
PSA Response Rate is defined as percentage of participants achieving >=30% decrease from Baseline PSA after 4 weeks of study treatment. The CI was calculated using exact two sided 95% CI for the percentage of participants with Baseline PSA values who show >=30% reduction in PSA at >=4 weeks post-Baseline.
- Time to Disease Progression [ Time Frame: Up to 21.3 months ]
Time to disease progression is defined as the time from date of first dose of study treatment to date of disease progression defined as one or more of the following criteria: 1. Radiographic progression by PCWG3-modified RECIST version 1.1 for participants with measurable disease, 2. Bone progression on bone scan according to the PCGW3 criteria, 3. PSA progression according to the PCWG3 criteria accompanied by any one of the following: investigator-defined clinical progression or either of the above RECIST version 1.1 radiographic progression or bone progression.
- Radiographic Progression-free Survival (rPFS) [ Time Frame: Up to 21.3 montths ]
rPFS is defined as the time from study treatment start until the first date of either disease progression or death due to any cause. The date of disease progression is defined as the earliest date of disease progression as assessed by the investigator using PCWG3-modified RECIST, version 1.1 or progression on bone scan. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
- Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Up to 21.3 months ]
Performance status assessments were based on 6-point ECOG scale (from 0 to 5), where 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work); 2=ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5=dead. Data for worst case post-Baseline is presented.
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS) [ Time Frame: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61 ]
EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value.
- Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours [ Time Frame: Baseline (Pre-dose on Week 1 Day 1) and on Day 1 of Weeks 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61, 73, 85, 97 ]
BPI-SF is 9-item self-administered questionnaire. Pain intensity score was calculated from the four items (items 3, 4, 5 and 6) for worst pain, least pain, average pain and current pain. Worst pain in last 24 hours was rated from 0 (no pain) to 10 (pain as bad as you can imagine). Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose (latest up to Week 1 Day 1). Change from Baseline was calculated as post-Baseline visit value minus Baseline value.
|
- Plasma concentration of GSK525762 and selected metabolites [ Time Frame: Day 1 of Week (W) 1 and W3 (Pre-dose, 30 minutes (m)±5m, 1h±10m, 3h±30m, 6 to 12 hours (h) and 24 h±2h prior to dosing); Day 1 of W5 (pre-dose, 0.5-1h post-dose, [optional] 4-12h post-dose); and every 8W from W9 to W49 (pre-dose and 0.5-1 h post-dose) ]
Concentration of GSK525762 will be determined following repeat-dose oral administration in combination with abiraterone or enzalutamide
- Plasma concentration of abiraterone or enzalutamide [ Time Frame: Day 1 of Week (W) 1 and W3 (Pre-dose, 30 minutes (m)±5m, 1h±10m, 3h±30m, 6 to 12 hours (h) and 24 h±2h prior to dosing); Day 1 of W5 (pre-dose, 0.5-1h post-dose, [optional] 4-12h post-dose); and every 8W from W9 to W49 (pre-dose and 0.5-1 h post-dose) ]
Concentration of abiraterone or enzalutamide will be determined following repeat-dose oral administration in combination with GSK525762
- Overall response rate (ORR) based on Prostate Cancer Working Group (PCWG3)-modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [ Time Frame: Approximately up to 3 years ]
The overall response rate is defined as complete response (CR) plus partial response (PR)
- Circulating Tumor Cell (CTC) response [ Time Frame: Approximately up to 3 years ]
CTC response rate is defined as reduction from ≤5 cells/7.5 milliliter (mL) blood to ≥5 cells/7.5 mL blood
- Percentage of subjects with PSA response at Week 4 [ Time Frame: Week 4 ]
PSA response is defined as percent of subjects achieving ≥30% decrease from baseline PSA at 4 weeks
- Time to disease progression [ Time Frame: Approximately up to 3 years ]
Time to disease progression will be evaluated either by PCWG3-modified RECIST 1.1, PSA progression, and/or progression in bone
- Radiographic Progression-free survival (rPFS) based on PCWG3-modified RECIST 1.1 [ Time Frame: Approximately up to 3 years ]
rPFS is defined as the time from study treatment start until the first date of either disease progression or death due to any cause
- Composite Response Rate defined as any one of the following: a) Response based on PCWG3-modified RECIST1.1, b) PSA decrease of ≥50% at Week 12 and thereafter, or c) Circulating Tumor-cell Count Conversion [ Time Frame: Approximately up to 3 years ]
CRR will be assessed.
- The performance status as measured by Eastern Cooperative Oncology Group (ECOG) scale [ Time Frame: Approximately up to 3 years ]
Performance status assessments are based on 5-point ECOG scale where 0 is fully active, able to carry on all pre-disease performance without restriction. 1 is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. 2 is ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50 percent of waking hrs. 3 is capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. 4 is completely disabled; cannot carry on any selfcare; totally confined to bed or chair. 5 is dead.
- The change in the quality of life as measured by European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) [ Time Frame: Approximately up to 3 years ]
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small. A change of 10 - 20 points is considered a moderate change.
- Pain as assessed with The Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Approximately up to 3 years ]
BPI-SF questionnaire is used to assess how pain interferes with patient's functioning in addition to measuring the intensity and location of pain.
|
- Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Until End of the Study [ Time Frame: Up to 3 years and 11 months ]
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function. Number of Participants With any AEs and SAEs collected from start of the treatment until end of the study were reported.
- Number of Participants With AEs Leading to Any Dose Reduction or Delays Until End of the Study [ Time Frame: Up to 3 years and 11 months ]
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of Participants with AEs leading to any dose reduction or delays from start of the treatment until end of the study were reported.
- Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment Until End of the Study [ Time Frame: Up to 3 years and 11 months ]
Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs from start of the treatment until end of the study were reported.
|
Not Provided
|
|
Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer
|
A Phase IB Open-label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Androgen Deprivation Therapy and Other Agents in Subjects With Castrate-resistant Prostate Cancer (CRPC)
|
This study aims to evaluate the combination of GSK525762 with other agents that have been shown to be effective in the treatment of CRPC or metastatic (m)CRPC. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in combination with either abiraterone (Arm A) or enzalutamide (Arm B).
|
Not Provided
|
Interventional
|
Phase 1
|
Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: This will be a two-arm, open-label dose escalation and dose expansion cohort study. Masking: None (Open Label) Primary Purpose: Treatment
|
Solid Tumours
|
- Drug: GSK525762
GSK525762 will be administered.
- Drug: Abiraterone
Abiraterone will be administered.
- Drug: Enzalutamide
Enzalutamide will be administered.
- Drug: Prednisone
Prednisone will be administered as a concomitant medication in combination with abiraterone
|
- Experimental: GSK525762 + Abiraterone (+ Prednisone) (Arm A)
Interventions:
- Drug: GSK525762
- Drug: Abiraterone
- Drug: Prednisone
- Experimental: GSK525762 + Enzalutamide (Arm B)
Interventions:
- Drug: GSK525762
- Drug: Enzalutamide
|
Not Provided
|
|
Terminated
|
73
|
130
|
June 22, 2021
|
July 31, 2020 (Final data collection date for primary outcome measure)
|
Inclusion Criteria:
- Written informed consent provided.
- Males >=18 years of age (at the time written consent is obtained for screening).
- Histologically confirmed adenocarcinoma of the prostate: screening and on-treatment biopsy is mandatory. If adequate number of paired biopsy samples are collected (>=20 paired samples for each dose level in each Arm, unless an Arm is closed early), then further biopsy sampling will be considered based on available data; screening biopsy can be waived if participant had a recent biopsy after failure of the most recent therapy (within 30 days) and the biopsy sample is secured to be sent as screening biopsy for this study.
- Surgically or medically castrated, with testosterone levels of less than or equal to (<=)50 nanograms per deciliter (ng/dL) (<2.0 nanometer [nM]). If the participant is being treated with luteinizing hormone-releasing hormone (LHRH) agonists/antagonists (participant who have not undergone orchiectomy) this therapy must have been initiated at least 4 weeks prior to Week 1 Day 1 and must be continued throughout the study.
-
Participants must have failed prior therapy with abiraterone, enzalutamide, or both:
- Has completed at least 12 weeks of prior continuous therapy with abiraterone or enzalutamide in any prior line.
- Lead-in dosing period for enzalutamide only will be required under the following circumstance:
(i) If the participant has enzalutamide discontinuation for >7 days prior to dosing start with GSK525762 plus enzalutamide on trial, then a enzalutamide only lead-in dosing of 28 days is required.
(ii) If the participant has enzalutamide discontinuation for <=7 days prior to dosing start with GSK525762 plus enzalutamide on trial, then an enzalutamide only lead-in dosing of 14 days is required.
(iii) If the participant is on continuous dosing with enzalutamide prior to dosing start with GSK525762 plus enzalutamide on trial, then participant can start on combined dosing at end of screening period.
(c) Lead-in dosing period for abiraterone only will be required: if the participant has abiraterone discontinuation for more than 3 days prior to dosing start with GSK525762 plus abiraterone on trial, then abiraterone only lead-in dosing of 7 days is required.
Exclusion Criteria:
|
Sexes Eligible for Study: |
Male |
Gender Based Eligibility: |
Yes |
|
18 Years and older (Adult, Older Adult)
|
No
|
Contact information is only displayed when the study is recruiting subjects
|
Australia, Spain, United Kingdom, United States
|
Canada, France
|
|
NCT03150056
|
204697 2016-003416-13 ( EudraCT Number )
|
No
|
Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
|
Plan to Share IPD: |
Yes |
Plan Description: |
IPD for this study will be made available via the Clinical Study Data Request site. |
Supporting Materials: |
Study Protocol |
Supporting Materials: |
Statistical Analysis Plan (SAP) |
Supporting Materials: |
Informed Consent Form (ICF) |
Supporting Materials: |
Clinical Study Report (CSR) |
Time Frame: |
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study. |
Access Criteria: |
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months. |
URL: |
http://clinicalstudydatarequest.com |
|
GlaxoSmithKline
|
Same as current
|
GlaxoSmithKline
|
Same as current
|
Not Provided
|
Study Director: |
GSK Clinical Trials |
GlaxoSmithKline |
|
GlaxoSmithKline
|
August 2022
|