nctId: NCT06322693 id: 213348 id: 2023-507564-39 type: EUDRACT_NUMBER briefTitle: A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) overallStatus: RECRUITING date: 2016-07-08 date: 2025-08-29 date: 2027-02-19 date: 2024-03-21 date: 2024-03-21 name: GlaxoSmithKline class: INDUSTRY briefSummary: This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy. conditions: Neoplasms studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a multi-center, open-label, first-in-human Phase 1 study. primaryPurpose: TREATMENT masking: NONE count: 475 type: ESTIMATED name: TSR-022 name: Nivolumab name: TSR-042 name: TSR-033 name: Docetaxel name: Pemetrexed name: Cisplatin name: Carboplatin measure: Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs) measure: Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs) measure: Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs) measure: Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs) measure: Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications measure: Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 measure: Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1 measure: Part 2 (A, B, C, D) : ORR by Immune related RECIST (irRECIST) measure: Part 2: Duration of response (DOR) by RECIST v 1.1 measure: Part 2 (A, B, C, D) : DOR by irRECIST measure: Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1 measure: Part 2 (A, B, C, D) : DCR by irRECIST measure: Part 2: Progression-free survival (PFS) by RECIST v 1.1 measure: Part 2 (A, B, C, D) : PFS by irRECIST measure: Parts 1 and 2 (A, B, C, D, E, F) : Serum concentration of TSR-022 measure: Part 1d: Serum concentration of TSR-033 measure: Part 1 (c, d, e, f, g ,h): Serum concentration of TSR-042 measure: Part 2 (A, B, C, D, F): Serum concentration of TSR-042 measure: Part 2: Overall survival (OS) measure: Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy measure: Part 1b: Cmin of TSR-022 in combination with nivolumab measure: Part 1c: Cmin of TSR-022 in combination with TSR-042 measure: Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy measure: Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab measure: Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042 measure: Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy measure: Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab measure: Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042 measure: Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapy measure: Part 1b: t1/2 of TSR-022 and in combination with nivolumab measure: Part 1c: t1/2 of TSR-022 in combination with TSR-042 measure: Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapy measure: Part 1b: AUCtau of TSR-022 and in combination with nivolumab measure: Part 1c: AUCtau of TSR-022 in combination with TSR-042 measure: Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022 measure: Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022 measure: Part 1 (c, d, e, f, g ,h): Number of participants with ADA to TSR-042 measure: Part 2 (A, B, C, D, F): Number of Participants with ADA to TSR-042 measure: Part 1d: Number of participants with ADA to TSR-033 measure: Part 2F: Number of participants with AEs, SAEs, AEs leading to discontinuation, TEAEs, TEAEs leading to death measure: Part 2F: Percent change from Baseline in Alpha-fetoprotein (AFP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site status: COMPLETED city: Goodyear state: Arizona zip: 85338 country: United States lat: 33.43532 lon: -112.35821 facility: GSK Investigational Site status: COMPLETED city: Scottsdale state: Arizona zip: 85258 country: United States lat: 33.50921 lon: -111.89903 facility: GSK Investigational Site status: COMPLETED city: Tucson state: Arizona zip: 85704 country: United States lat: 32.22174 lon: -110.92648 facility: GSK Investigational Site status: COMPLETED city: Tucson state: Arizona zip: 85711 country: United States lat: 32.22174 lon: -110.92648 facility: GSK Investigational Site status: RECRUITING city: Encinitas state: California zip: 92024 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Edward F McClay role: PRINCIPAL_INVESTIGATOR lat: 33.03699 lon: -117.29198 facility: GSK Investigational Site status: RECRUITING city: Fountain Valley state: California zip: 92708 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Haresh S. Jhangiani role: PRINCIPAL_INVESTIGATOR lat: 33.70918 lon: -117.95367 facility: GSK Investigational Site status: RECRUITING city: Los Angeles state: California zip: 90024 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Antoni Ribas role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: GSK Investigational Site status: RECRUITING city: Los Angeles state: California zip: 90025 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Peter D Boasberg role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: GSK Investigational Site status: RECRUITING city: San Marcos state: California zip: 92069 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Edward F McClay role: PRINCIPAL_INVESTIGATOR lat: 33.14337 lon: -117.16614 facility: GSK Investigational Site status: RECRUITING city: Whittier state: California zip: 90606 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Paul La Porte role: PRINCIPAL_INVESTIGATOR lat: 33.97918 lon: -118.03284 facility: GSK Investigational Site status: RECRUITING city: Aurora state: Colorado zip: 80012 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Allen L. Cohn role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: GSK Investigational Site status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Theresa Medina role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: GSK Investigational Site status: COMPLETED city: Denver state: Colorado zip: 80218 country: United States lat: 39.73915 lon: -104.9847 facility: GSK Investigational Site status: RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Gerald Falchook role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 facility: GSK Investigational Site status: RECRUITING city: New Haven state: Connecticut zip: 06511 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Patricia M Lorusso role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: GSK Investigational Site status: RECRUITING city: Washington state: District of Columbia zip: 20007 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Michael Pishvaian role: PRINCIPAL_INVESTIGATOR lat: 38.89511 lon: -77.03637 facility: GSK Investigational Site status: COMPLETED city: Jacksonville state: Florida zip: 32224 country: United States lat: 30.33218 lon: -81.65565 facility: GSK Investigational Site status: COMPLETED city: Miami Beach state: Florida zip: 33140 country: United States lat: 25.79065 lon: -80.13005 facility: GSK Investigational Site status: RECRUITING city: Sarasota state: Florida zip: 34232 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Judy S Wang role: PRINCIPAL_INVESTIGATOR lat: 27.33643 lon: -82.53065 facility: GSK Investigational Site status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Zeynep Eroglu role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: GSK Investigational Site status: COMPLETED city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: GSK Investigational Site status: COMPLETED city: Augusta state: Georgia zip: 30912 country: United States lat: 33.47097 lon: -81.97484 facility: GSK Investigational Site status: RECRUITING city: Arlington Heights state: Illinois zip: 60005 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Richard S Siegel role: PRINCIPAL_INVESTIGATOR lat: 42.08836 lon: -87.98063 facility: GSK Investigational Site status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jason J Luke role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: GSK Investigational Site status: RECRUITING city: Niles state: Illinois zip: 60714 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Richard S Siegel role: PRINCIPAL_INVESTIGATOR lat: 42.01892 lon: -87.80284 facility: GSK Investigational Site status: RECRUITING city: Iowa City state: Iowa zip: 52242-1009 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Mohammed Milhem role: PRINCIPAL_INVESTIGATOR lat: 41.66113 lon: -91.53017 facility: GSK Investigational Site status: COMPLETED city: Wichita state: Kansas zip: 67214 country: United States lat: 37.69224 lon: -97.33754 facility: GSK Investigational Site status: COMPLETED city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: GSK Investigational Site status: RECRUITING city: Pikeville state: Kentucky zip: 41501 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Christopher C. Croot role: PRINCIPAL_INVESTIGATOR lat: 37.47927 lon: -82.51876 facility: GSK Investigational Site status: RECRUITING city: Rockville state: Maryland zip: 20850 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: John M Wallmark role: PRINCIPAL_INVESTIGATOR lat: 39.084 lon: -77.15276 facility: GSK Investigational Site status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Keith Flaherty role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: GSK Investigational Site status: COMPLETED city: Detroit state: Michigan zip: 48202 country: United States lat: 42.33143 lon: -83.04575 facility: GSK Investigational Site status: COMPLETED city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 facility: GSK Investigational Site status: COMPLETED city: Hackensack state: New Jersey zip: 07601 country: United States lat: 40.88593 lon: -74.04347 facility: GSK Investigational Site status: RECRUITING city: Bronx state: New York zip: 10461 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Sanjay Goel role: PRINCIPAL_INVESTIGATOR lat: 40.84985 lon: -73.86641 facility: GSK Investigational Site status: RECRUITING city: New York state: New York zip: 10016 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Janice Mehnert role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: GSK Investigational Site status: COMPLETED city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 facility: GSK Investigational Site status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: David Bajor role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: GSK Investigational Site status: RECRUITING city: Toledo state: Ohio zip: 43623 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Rex B Mowat role: PRINCIPAL_INVESTIGATOR lat: 41.66394 lon: -83.55521 facility: GSK Investigational Site status: RECRUITING city: Eugene state: Oregon zip: 97401 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Joseph Fiorillo role: PRINCIPAL_INVESTIGATOR lat: 44.05207 lon: -123.08675 facility: GSK Investigational Site status: COMPLETED city: Portland state: Oregon zip: 97213-2982 country: United States lat: 45.52345 lon: -122.67621 facility: GSK Investigational Site status: COMPLETED city: Bethlehem state: Pennsylvania zip: 18015 country: United States lat: 40.62593 lon: -75.37046 facility: GSK Investigational Site status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15213-2584 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Diwakar Davar role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: GSK Investigational Site status: RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Theodore G Gourdin role: PRINCIPAL_INVESTIGATOR lat: 32.77657 lon: -79.93092 facility: GSK Investigational Site status: COMPLETED city: Greenville state: South Carolina zip: 29605 country: United States lat: 34.85262 lon: -82.39401 facility: GSK Investigational Site status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jeffrey Roger Infante role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: GSK Investigational Site status: COMPLETED city: Austin state: Texas zip: 78705 country: United States lat: 30.26715 lon: -97.74306 facility: GSK Investigational Site status: RECRUITING city: Dallas state: Texas zip: 75246 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Charles L Cowey role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: GSK Investigational Site status: COMPLETED city: Fort Worth state: Texas zip: 76104 country: United States lat: 32.72541 lon: -97.32085 facility: GSK Investigational Site status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Julio Peguero role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: GSK Investigational Site status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Timothy Yap role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: GSK Investigational Site status: RECRUITING city: Longview state: Texas zip: 75601 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Donald Richards role: PRINCIPAL_INVESTIGATOR lat: 32.5007 lon: -94.74049 facility: GSK Investigational Site status: RECRUITING city: McAllen state: Texas zip: 78503-1298 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Habib M. H. Ghaddar role: PRINCIPAL_INVESTIGATOR lat: 26.20341 lon: -98.23001 facility: GSK Investigational Site status: COMPLETED city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 facility: GSK Investigational Site status: COMPLETED city: Temple state: Texas zip: 76508 country: United States lat: 31.09823 lon: -97.34278 facility: GSK Investigational Site status: RECRUITING city: Tyler state: Texas zip: 75702 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Donald Richards role: PRINCIPAL_INVESTIGATOR lat: 32.35126 lon: -95.30106 facility: GSK Investigational Site status: RECRUITING city: Weslaco state: Texas zip: 78596 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Habib M. H. Ghaddar role: PRINCIPAL_INVESTIGATOR lat: 26.15952 lon: -97.99084 facility: GSK Investigational Site status: RECRUITING city: Fairfax state: Virginia zip: 8613 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Alexander I. Spira role: PRINCIPAL_INVESTIGATOR lat: 38.84622 lon: -77.30637 facility: GSK Investigational Site status: RECRUITING city: Kennewick state: Washington zip: 99336 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Ying Zhuo role: PRINCIPAL_INVESTIGATOR lat: 46.21125 lon: -119.13723 facility: GSK Investigational Site status: RECRUITING city: Puyallup state: Washington zip: 98373 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Andrea Veatch role: PRINCIPAL_INVESTIGATOR lat: 47.18538 lon: -122.2929 facility: GSK Investigational Site status: RECRUITING city: Tacoma state: Washington zip: 98405 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Andrea Veatch role: PRINCIPAL_INVESTIGATOR lat: 47.25288 lon: -122.44429 facility: GSK Investigational Site status: COMPLETED city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 facility: GSK Investigational Site status: RECRUITING city: Daegu zip: 41931 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Sun Hyo Park role: PRINCIPAL_INVESTIGATOR lat: 35.87028 lon: 128.59111 facility: GSK Investigational Site status: RECRUITING city: Seongnam-si, Gyeonggi-do zip: 13620 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yu Jung kim role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Seoul zip: 02841 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yoon Ji Choi role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Hye Ryun Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Myung-Ju Ahn role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site status: RECRUITING city: Seoul zip: 7061 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jin-Soo Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site status: RECRUITING city: Palma de Mallorca state: Islas Baleares zip: 07120 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Aitor Azkárate Martínez role: PRINCIPAL_INVESTIGATOR lat: 39.56939 lon: 2.65024 facility: GSK Investigational Site status: RECRUITING city: Madrid state: Navarra zip: 28027 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Eduardo Castanon Alvarez role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site status: RECRUITING city: Barcelona zip: 08017 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Santiago Viteri Ramírez role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site status: RECRUITING city: Barcelona zip: 08035 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Enriqueta Felip role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site status: RECRUITING city: Barcelona zip: 8028 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Andrés Aguilar Hernández role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site status: RECRUITING city: Girona zip: 17007 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Joaquim Bosch Barrera role: PRINCIPAL_INVESTIGATOR lat: 41.98311 lon: 2.82493 facility: GSK Investigational Site status: RECRUITING city: Jerez de la Frontera zip: 11407 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jesús Corral Jaime role: PRINCIPAL_INVESTIGATOR lat: 36.68645 lon: -6.13606 facility: GSK Investigational Site status: RECRUITING city: L'Hospitalet De Llobregat zip: 08908 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: María Jové Casulleras role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 facility: GSK Investigational Site status: RECRUITING city: Las Palmas De Gran Canaria zip: 35016 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Delvys Rodriguez Abreu role: PRINCIPAL_INVESTIGATOR lat: 28.09973 lon: -15.41343 facility: GSK Investigational Site status: RECRUITING city: Madrid zip: 28040 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Victor Moreno Garcia role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site status: RECRUITING city: Madrid zip: 28041 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Luis Paz Ares role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site status: RECRUITING city: Madrid zip: 28046 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Javier De Castro Carpeno role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site status: RECRUITING city: Majadahonda (Madrid) zip: 28222 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Mariano Provencio Pulla role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Málaga zip: 29010 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jose Manuel Trigo Pérez role: PRINCIPAL_INVESTIGATOR lat: 36.72016 lon: -4.42034 facility: GSK Investigational Site status: COMPLETED city: Pamplona zip: 31008 country: Spain lat: 42.81687 lon: -1.64323 facility: GSK Investigational Site status: RECRUITING city: Santander zip: 39008 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Marta López-Brea Piqueras role: PRINCIPAL_INVESTIGATOR lat: 43.46472 lon: -3.80444 facility: GSK Investigational Site status: RECRUITING city: Sevilla zip: 41013 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Amparo Sánchez Gastaldo role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 facility: GSK Investigational Site status: RECRUITING city: Valencia zip: 46010 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Desamparados Roda Pérez role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: GSK Investigational Site status: RECRUITING city: Valencia zip: 46026 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Oscar Juan Vidal role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False