Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1 First Time in Human (FTIH), Open Label Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843359
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE February 18, 2019
Last Update Posted Date June 22, 2022
Actual Study Start Date  ICMJE March 12, 2019
Estimated Primary Completion Date November 18, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2021)
  • Parts 1A and 2A: Number of participants achieving dose-limiting toxicity (DLT) [ Time Frame: Up to Day 29 ]
  • Parts 1A and 2A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • 1A: Number of subjects achieving Dose-limiting toxicity (DLT) [ Time Frame: Up to Day 21 ]
    DLT is defined as any Grade 3 or 4 cytokine release syndrome; alanine aminotransferase (ALT) >=3 times upper limit of normal (ULN),plus bilirubin >=2 times ULN (>35% direct) or plus international normalized ratio (INR)>1.5 (possible Hy's law);or both ALT >=5 times ULN and >=2 times Baseline value (in subjects with liver metastases/tumor infiltration at Baseline);Grade >=3 non-hematologic toxicity of any duration with exceptions: Transient (<=72 hours) abnormal laboratory value without associated clinically significant signs or symptoms; Nausea, vomiting, or diarrhea adequately controlled with supportive care within 48 hours;Alopecia; Grade >=3 fatigue in subjects with Baseline fatigue of grade <=2. Grade >=3 immune related toxicity;any other event which in judgment of investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT;Grade 4 anemia;Grade 4 neutropenia of >7 days duration or febrile neutropenia;Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding.
  • 1A: Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or requires medical judgement.
  • 1A: Severity of AEs [ Time Frame: Up to 2 years ]
    The severity of AEs will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
  • 2A: Number of subjects achieving DLT [ Time Frame: Up to Day 29 ]
    DLT is defined as any Grade 3 or 4 cytokine release syndrome; ALT >=3 times ULN,plus bilirubin >=2 times ULN (>35% direct) or plus INR>1.5 (possible Hy's law);or both ALT >=5 times ULN and >=2 times Baseline value (in subjects with liver metastases/tumor infiltration at Baseline);Grade >=3 non-hematologic toxicity of any duration with exceptions: Transient (<=72 hours) abnormal laboratory value without associated clinically significant signs or symptoms; Nausea, vomiting, or diarrhea adequately controlled with supportive care within 48 hours;Alopecia; Grade >=3 fatigue in subjects with Baseline fatigue of grade <=2. Grade >=3 immune related toxicity;any other event which in judgment of investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT;Grade 4 anemia;Grade 4 neutropenia of >7 days duration or febrile neutropenia;Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding.
  • 2A: Number of subjects with AEs and SAEs [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or requires medical judgement.
  • 2A: Severity of AEs [ Time Frame: Up to 2 years ]
    The severity of AEs will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
  • 1B: Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria [ Time Frame: Up to 2 years ]
    Objective response rate is defined as the percentage of subjects with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria.
  • 2B: Objective response rate based on RECIST 1.1 criteria [ Time Frame: Up to 2 years ]
    Objective response rate is defined as the percentage of subjects with a best overall confirmed CR or PR at any time as per disease-specific criteria.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2021)
  • Part 1A: GSK3745417 concentrations in plasma following administration of GSK3745417 alone [ Time Frame: Up to Week 104 ]
  • Part 1A: Maximum observed concentration (Cmax) following administration of GSK3745417 alone [ Time Frame: Up to Week 104 ]
  • Part 1A: Area under the concentration-time curve (AUC) following administration of GSK3745417 alone [ Time Frame: Up to Week 104 ]
  • Part 1A: Apparent terminal phase half-life (t1/2) following administration of GSK3745417 alone [ Time Frame: Up to Week 104 ]
  • Part 2A: GSK3745417 concentrations in plasma following administration of GSK3745417 in combination with dostarlimab [ Time Frame: Up to Week 104 ]
  • Part 2A: Cmax following administration of GSK3745417 in combination with dostarlimab [ Time Frame: Up to Week 104 ]
  • Part 2A: AUC following administration of GSK3745417 in combination with dostarlimab [ Time Frame: Up to Week 104 ]
  • Part 2A: T1/2 following administration of GSK3745417 in combination with dostarlimab [ Time Frame: Up to Week 104 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • 1A: Best objective response based on RECIST 1.1 criteria [ Time Frame: Up to 2 years ]
    Best objective response rate is defined as the percentage of subjects with a best overall confirmed CR or PR at any time as per disease-specific criteria.
  • 1A: GSK3745417 concentrations in plasma following administration of GSK3745417 alone [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-injection at Weeks 1, 2, 3, 4, 5, 6, 9 and 12 ]
    Blood samples will be collected at indicated time points for plasma pharmacokinetic (PK) analysis of GSK3745417.
  • 1A: Maximum observed concentration (Cmax) following administration of GSK3745417 alone [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-injection at Weeks 1, 2, 3, 4, 5, 6, 9 and 12 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 monotherapy.
  • 1A: Area under the concentration-time curve (AUC) following administration of GSK3745417 alone [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-injection at Weeks 1, 2, 3, 4, 5, 6, 9 and 12 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 monotherapy.
  • 1A: Apparent terminal phase half-life (t½) following administration of GSK3745417 alone [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-injection at Weeks 1, 2, 3, 4, 5, 6, 9 and 12 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 monotherapy.
  • 2A: Best objective response based on RECIST 1.1 criteria [ Time Frame: Up to 2 years ]
    Best objective response rate is defined as the percentage of subjects with a best overall confirmed CR or PR at any time as per disease-specific criteria.
  • 2A: GSK3745417 concentrations in plasma following administration of GSK3745417 in combination with pembrolizumab [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post injection at Weeks 1, 2, 5, 8, 11, 14 and 17 ]
    Blood samples will be collected for plasma PK analysis of GSK3745417 following administration of GSK3745417 in combination with pembrolizumab.
  • 2A: Cmax following administration of GSK3745417 in combination with pembrolizumab [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post injection at Weeks 1, 2, 5, 8, 11, 14 and 17 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 in combination with pembrolizumab.
  • 2A: AUC following administration of GSK3745417 in combination with pembrolizumab [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post injection at Weeks 1, 2, 5, 8, 11, 14 and 17 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 in combination with pembrolizumab.
  • 2A: t½ following administration of GSK3745417 in combination with pembrolizumab [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post injection at Weeks 1, 2, 5, 8, 11, 14 and 17 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 in combination with pembrolizumab.
  • 1B: Number of subjects achieving DLT [ Time Frame: Up to Day 21 ]
    DLT is defined as any Grade 3 or 4 cytokine release syndrome; ALT >=3 times ULN,plus bilirubin >=2 times ULN (>35% direct) or plus INR>1.5 (possible Hy's law);or both ALT >=5 times ULN and >=2 times Baseline value (in subjects with liver metastases/tumor infiltration at Baseline);Grade >=3 non-hematologic toxicity of any duration with exceptions: Transient (<=72 hours) abnormal laboratory value without associated clinically significant signs or symptoms; Nausea, vomiting, or diarrhea adequately controlled with supportive care within 48 hours;Alopecia; Grade >=3 fatigue in subjects with Baseline fatigue of grade <=2. Grade >=3 immune related toxicity;any other event which in judgment of investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT;Grade 4 anemia;Grade 4 neutropenia of >7 days duration or febrile neutropenia;Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding.
  • 1B: Number of subjects with AEs and SAEs [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or requires medical judgement.
  • 1B: Severity of AEs [ Time Frame: Up to 2 years ]
    The severity of AEs will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
  • 1B: GSK3745417 concentrations in plasma following administration of GSK3745417 alone [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-injection at Weeks 1, 2, 3, 4, 5, 6, 9 and 12 ]
    Blood samples will be collected at indicated time points for plasma PK analysis of GSK3745417.
  • 1B: Cmax following administration of GSK3745417 alone [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-injection at Weeks 1, 2, 3, 4, 5, 6, 9 and 12 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 alone.
  • 1B: AUC following administration of GSK3745417 alone [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-injection at Weeks 1, 2, 3, 4, 5, 6, 9 and 12 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 alone.
  • 1B: t½ following administration of GSK3745417 alone [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-injection at Weeks 1, 2, 3, 4, 5, 6, 9 and 12 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 alone.
  • 2B: Number of subjects achieving DLT [ Time Frame: Up to Day 29 ]
    DLT is defined as any Grade 3 or 4 cytokine release syndrome; ALT >=3 times ULN,plus bilirubin >=2 times ULN (>35% direct) or plus INR>1.5 (possible Hy's law);or both ALT >=5 times ULN and >=2 times Baseline value (in subjects with liver metastases/tumor infiltration at Baseline);Grade >=3 non-hematologic toxicity of any duration with exceptions: Transient (<=72 hours) abnormal laboratory value without associated clinically significant signs or symptoms; Nausea, vomiting, or diarrhea adequately controlled with supportive care within 48 hours;Alopecia; Grade >=3 fatigue in subjects with Baseline fatigue of grade <=2. Grade >=3 immune related toxicity;any other event which in judgment of investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT;Grade 4 anemia;Grade 4 neutropenia of >7 days duration or febrile neutropenia;Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding.
  • 2B: 2B: Number of subjects with AEs and SAEs [ Time Frame: Up to 2 years ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or requires medical judgement.
  • 2B: Severity of AEs [ Time Frame: Up to 2 years ]
    The severity of AEs will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
  • 2B: GSK3745417 concentrations in plasma following administration of GSK3745417 in combination with pembrolizumab [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post injection at Weeks 1, 2, 5, 8, 11, 14 and 17 ]
    Blood samples will be collected at indicated time points for plasma PK analysis of GSK3745417.
  • 2B: Cmax following administration of GSK3745417 in combination with pembrolizumab [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post injection at Weeks 1, 2, 5, 8, 11, 14 and 17 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 in combination with pembrolizumab.
  • 2B: AUC following administration of GSK3745417 in combination with pembrolizumab [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post injection at Weeks 1, 2, 5, 8, 11, 14 and 17 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 in combination with pembrolizumab.
  • 2B: t½ following administration of GSK3745417 in combination with pembrolizumab [ Time Frame: Pre-dose, 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post injection at Weeks 1, 2, 5, 8, 11, 14 and 17 ]
    Blood samples will be collected at indicated time points for plasma PK analysis following administration of GSK3745417 in combination with pembrolizumab.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 First Time in Human (FTIH), Open Label Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
Official Title  ICMJE A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors
Brief Summary This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
In Part 1A, escalating doses of GSK3745417 will be evaluated and in Part 2A, escalating doses of GSK3745417 in combination with dostarlimab will be evaluated as guided by the Bayesian Logistic Regression Model (BLRM). Part 1B (monotherapy dose expansion) & Part 2B (combination therapy dose expansion) will be planned upon conclusion of dose escalation parts.
Masking: None (Open Label)
Masking Description:
This will be an Open-label study.
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: GSK3745417
    GSK3745417 will be administered.
  • Drug: Dostarlimab
    Dostarlimab will be administered.
Study Arms  ICMJE
  • Experimental: Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort
    Intervention: Drug: GSK3745417
  • Experimental: Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort
    Interventions:
    • Drug: GSK3745417
    • Drug: Dostarlimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 22, 2025
Estimated Primary Completion Date November 18, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant must be more than or equal to (>=)18 years of age.
  • Participants with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.
  • Histological or cytological documentation of an advanced solid tumor.
  • Participants must provide a fresh biopsy.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  • Adequate organ function per protocol specifications.
  • Male or female participants.
  • Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception.
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Active autoimmune disease that has required systemic disease modifying or immunosuppressive treatment within the last 2 years.
  • Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment.
  • Current unstable liver or biliary disease.
  • History of vasculitis at any time prior to study treatment.
  • Evidence or history of significant active bleeding or coagulation disorder.
  • Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C.
  • QT duration corrected for heart rate by Fridericia's formula (QTcF) more than (>)450 milliseconds (msec) or QTcF >480 msec for participants with bundle branch block.
  • Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
  • Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
  • History or evidence of cardiovascular (CV) risk
  • Recent (within the past 6 months) history of symptomatic pericarditis.
  • History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis.
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
  • Prior treatment with the following agents:

    1. Stimulator of Interferon Genes (STING) agonist at any time.
    2. Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter.
    3. Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), Programmed death Ligand-1 (PD-L1), PD-L2 and Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors within 28 days.
    4. Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented.
  • Pregnant and/or breast feeding participants or those who plan to become pregnant and/or breastfeed.
  • Receipt of any live vaccine within 30 days of the start of study treatment.
  • Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
  • Major surgery less than or equal to (<=)28 days before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
  • Participants with signs/symptoms suggestive of Coronavirus Disease-2019 (COVID-19) within 14 days of study entry, or with known exposure to COVID-19 within 14 days prior to study entry.
  • Participants are excluded from Part 2A of the study if they have known hypersensitivity to dostarlimab or associated excipients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Listed Location Countries  ICMJE Australia,   Canada,   France,   Korea, Republic of,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03843359
Other Study ID Numbers  ICMJE 208850
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party GlaxoSmithKline
Original Responsible Party Same as current
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP