Solid Tumors Clinical Trial
Official title:
Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.
Status | Recruiting |
Enrollment | 920 |
Est. completion date | September 25, 2032 |
Est. primary completion date | September 25, 2032 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy - Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC) - Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50% - For participants aged >= 18 and <18 years: adequate hematologic and end-organ function - Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment - Adequate recovery from most recent systemic or local treatment for cancer - Life expectancy >= 8 weeks - Ability to comply with the study protocol, in the investigator's judgment - For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period - For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria - In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort Exclusion Criteria: - Current participation or enrollment in another therapeutic clinical trial - Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment - Whole brain radiotherapy within 14 days prior to start of study treatment - Stereotactic radiosurgery within 7 days prior to start of study treatment - Pregnant or breastfeeding, or intending to become pregnant during the study - History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study - Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina - History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy - In addition to the general exclusion criteria above, in order to be enrolled in a treatment cohort of the study, participants must not meet any of the cohort-specific exclusion criteria |
Country | Name | City | State |
---|---|---|---|
Australia | Kinghorn Cancer Centre; St Vincents Hospital | Darlinghurst | New South Wales |
Australia | Peter MacCallum Cancer Centre; Medical Oncology | Melbourne | Victoria |
Australia | Royal Children's Hospital | Parkville | Victoria |
Australia | Sydney Children's Hospital | Randwick | New South Wales |
Australia | Royal Darwin Hospital; Alan Walker Cancer Centre | Tiwi | Northern Territory |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Belgium | Cliniques Universitaires St-Luc | Bruxelles | |
Belgium | GHdC Site Notre Dame | Charleroi | |
Belgium | UZ Antwerpen | Edegem | |
Belgium | UZ Gent | Gent | |
Belgium | UZ Leuven Gasthuisberg | Leuven | |
Brazil | Hospital Moinhos de Vento | Porto Alegre | RS |
Brazil | Clínica Onco Star - Rede D'Or | Sao Paulo | SP |
Brazil | Hospital A. C. Camargo; Oncologia | Sao Paulo | SP |
Brazil | Hospital Sírio-Libanês | Sao Paulo | SP |
Brazil | Hospital Sírio-Libanês | Sao Paulo | SP |
Canada | London Health Sciences Centre · Victoria Hospital; Department of Medicine | London | Ontario |
Canada | McGill University Health Center | Montreal | Quebec |
Canada | The Ottawa Hospital - General Campus | Ottawa | Ontario |
Canada | Princess Margaret Cancer Center | Toronto | Ontario |
Canada | The Hospital for Sick Children | Toronto | Ontario |
Canada | BC Cancer ? Vancouver | Vancouver | British Columbia |
China | Beijing Cancer Hospital | Beijing | |
China | Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department | Beijing City | |
China | Jilin Cancer Hospital | Changchun | |
China | The First Hospital of Jilin University | Changchun City | |
China | West China Hospital - Sichuan University | Chengdu City | |
China | Shanghai East Hospital | Shanghai | |
China | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | |
China | Zhongshan Hospital Fudan Unvierstiy | Shanghai City | |
China | Tianjin Cancer Hospital | Tianjin | |
China | First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | |
Denmark | Aalborg Universitetshospital | Aalborg | |
Denmark | Aarhus Universitetshospital; Kræftafdelingen | Aarhus N | |
Denmark | Rigshospitalet; Onkologisk Klinik | København Ø | |
France | Institut Bergonie; Oncologie | Bordeaux | |
France | Centre Oscar Lambret; Service de Pediatrie | Lille | |
France | CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie | Lyon | |
France | Hopital de la Timone | Marseille | |
France | Institut Universitaire du Cancer de Toulouse-Oncopole | Toulouse | |
France | Institut de Cancerologie Gustave-Roussy (IGR) | Villejuif | |
Germany | Uniklinik Essen | Essen | |
Germany | Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I | Freiburg | |
Germany | Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie | Göttingen | |
Germany | Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II | Hamburg | |
Germany | Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie | Hannover | |
Germany | Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg | Heidelberg | |
Germany | SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm. | Heilbronn | |
Germany | Praxis für Hämatologie, Onkologie und Palliativmedizin | Mönchengladbach | |
Germany | Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III | München | |
Germany | Universtitätsklinikum Ulm; Klinik für Innere Medizin III | Ulm | |
Germany | Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU | Würzburg | |
Hong Kong | Hong Kong Children's Hospital | Hong Kong | |
Hong Kong | Prince of Wales Hospital; Department of Clinical Onocology | Shatin | |
Israel | Rambam Health Care Campus; Oncology | Haifa | |
Israel | Hadassah University Hospital - Ein Kerem | Jerusalem | |
Israel | Rabin MC; Davidof Center - Oncology Institute | Petach Tikva | |
Israel | Sheba Medical Center | Ramat Gan | |
Israel | Sourasky / Ichilov Hospital; Dept. of Oncology | Tel Aviv | |
Italy | Asst Degli Spedali Civili Di Brescia | Brescia | Lombardia |
Italy | Azienda Ospedaliera Meyer; Centro di Eccellenza di Oncologia ed Ematologia Pediatrica | Firenze | Toscana |
Italy | Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 | Milano | Lombardia |
Italy | Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica | Milano | Lombardia |
Italy | Istituto Nazionale Tumori Fondazione G. Pascale | Napoli | Campania |
Italy | Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica | Roma | Lazio |
Italy | Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1 | Roma | Lazio |
Italy | Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica | Siena | Toscana |
Italy | Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita | Torino | Piemonte |
Japan | National Cancer Center Hospital East | Chiba | |
Japan | Kindai University Hospital | Osaka | |
Japan | National Cancer Center Hospital | Tokyo | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center- Adult Site | Seoul | |
Korea, Republic of | Samsung Medical Center- Pediatric Site | Seoul | |
Korea, Republic of | Seoul National University Hospital- Adult Site | Seoul | |
Korea, Republic of | Seoul National University Hospital- Pediatric Site | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Netherlands | Prinses Maxima Centrum | Utrecht | |
New Zealand | Auckland City Hospital, Cancer and Blood Research | Auckland | |
New Zealand | Christchurch Hospital; Dept of Oncology | Christchurch | |
Poland | Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | |
Poland | Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers | Warszawa | |
Portugal | IPO do Porto; Servico de Oncologia Medica | Porto | |
Puerto Rico | PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center | San Juan | |
Singapore | National Cancer Centre; Medical Oncology | Singapore | |
Singapore | National University Hospital; National University Cancer Institute, Singapore (NCIS) | Singapore | |
South Africa | Medical Oncology Centre of Rosebank; Oncology | Johannesburg | |
Spain | Vall d?Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | |
Spain | Hospital Sant Joan De Deu | Esplugues De Llobregas | Barcelona |
Spain | Clinica Universidad de Navarra Madrid; Servicio de Oncología | Madrid | |
Spain | Hospital Infantil Universitario Nino Jesus | Madrid | |
Spain | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | |
Spain | Hospital Universitario La Paz; Servicio de Oncologia | Madrid | |
Spain | START Madrid-FJD, Hospital Fundacion Jimenez Diaz | Madrid | |
Spain | START Madrid. Centro Integral Oncologico Clara Campal; CIOCC | Madrid | |
Spain | Hospital Univ Vall d'Hebron; Servicio de Oncologia | Sant Andreu de La Barca | Barcelona |
Spain | Hospital Universitario la Fe; Servicio de Oncologia | Valencia | |
Switzerland | Universitätsspital Basel (USB) | Basel | |
Switzerland | Ospedale Regionale di Bellinzona Medizin Onkologie | Bellinzona | |
Switzerland | Inselspital, Klinik und Poliklinik für Medizinische Onkologie | Bern | |
Switzerland | Unversitätsspital Zürich | Zürich | |
Taiwan | Taichung Veterans General Hospital; Division of Hema-Oncology | Taichung | |
Taiwan | National Cheng Kung University Hospital; Oncology | Tainan | |
Taiwan | Taipei Veterans General Hospital; Department of Oncology | Taipei City | |
Taiwan | Chang Gung Memorial Hospital-Linkou; Dept of Oncology | Taoyuan County | |
Taiwan | National Taiwan University Hospital; Oncology | Zhongzheng Dist. | |
United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | |
United Kingdom | Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | |
United Kingdom | University College London Hospital | London | |
United Kingdom | Royal Manchester Children?s Hospital | Manchester | |
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United Kingdom | Royal Marsden Hospital (Sutton) | Sutton | |
United States | University of New Mexico; Comprehensive Cancer Center | Albuquerque | New Mexico |
United States | St. Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | University Cancer & Blood Center, LLC; Research | Athens | Georgia |
United States | Children's Hospital Colorado; Center For Cancer/Blood Disorder | Aurora | Colorado |
United States | Texas Onc-Central Austin CA Ct | Austin | Texas |
United States | Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana | Billings | Montana |
United States | St. Alphonsus | Boise | Idaho |
United States | Eastchester Center for Cancer Care | Bronx | New York |
United States | Montefiore Einstein Center for Cancer Care | Bronx | New York |
United States | Consultants in Medical Oncology and Hematology | Broomall | Pennsylvania |
United States | Levine Cancer Institute | Charlotte | North Carolina |
United States | Barrett Cancer Center | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc | Cincinnati | Ohio |
United States | Mary Crowley Medical Research Center | Dallas | Texas |
United States | Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
United States | Southern Cancer Center | Daphne | Alabama |
United States | Henry Ford Health System | Detroit | Michigan |
United States | City of Hope National Medical Center | Duarte | California |
United States | New York Cancer and Blood Specialists - Setauket Medical Oncology | East Setauket | New York |
United States | Cook Childrens Medical Center | Fort Worth | Texas |
United States | University of Florida | Gainesville | Florida |
United States | The West Clinic; West Cancer Center | Germantown | Tennessee |
United States | Western Regional Medical Center at Cancer Treatment Centers of America | Goodyear | Arizona |
United States | PRISMA Health - Greenville | Greenville | South Carolina |
United States | Alliance Cancer Specialists | Horsham | Pennsylvania |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Horizon Oncology Research, Inc. | Lafayette | Indiana |
United States | Comprehensive Cancer Centers of Nevada - Eastern Avenue | Las Vegas | Nevada |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Virginia Cancer Specialists - Leesburg | Leesburg | Virginia |
United States | Kaiser Permanente Los Angeles; Clinic/Infusion -LA | Los Angeles | California |
United States | USC Norris Cancer Center | Los Angeles | California |
United States | St. Jude Children'S Research Hospital | Memphis | Tennessee |
United States | Miami Cancer Institute of Baptist Health, Inc. | Miami | Florida |
United States | Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | National Translational Research Group | New York | New York |
United States | Christiana Care Health Srvcs; Helen F Graham Can Center | Newark | Delaware |
United States | Hoag Memorial Hospital | Newport Beach | California |
United States | Ocala Oncology Center | Ocala | Florida |
United States | Nebraska Methodist Hospital; Cancer Center | Omaha | Nebraska |
United States | Cancer Treatment Centers of America; Eastern Regional Medical Center | Philadelphia | Pennsylvania |
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | UC Davis Comprehensive Cancer Center | Sacramento | California |
United States | Washington University | Saint Louis | Missouri |
United States | Metro-Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota |
United States | University of California at San Francisco | San Francisco | California |
United States | Sarcoma Oncology Center | Santa Monica | California |
United States | New England Cancer Specialists | Scarborough | Maine |
United States | Maryland Hematology & Oncology. P.A. | Silver Spring | Maryland |
United States | Northwest Medical Specialties, PLLC; Research Department | Tacoma | Washington |
United States | Texas Oncology- Northeast Texas | Tyler | Texas |
United States | Midwestern Regional Med Center | Zion | Illinois |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All Cohorts: Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed objective response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) | Confirmed objective response indicates >/= 4 weeks after initial documentation of response | Approximately up to 12 years | |
Secondary | All Cohorts: IRC-assessed duration of response (DOR) per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | All Cohorts: IRC-assessed clinical benefit rate (CBR) per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | All Cohorts: IRC-assessed progression free survival (PFS) per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | All Cohorts: INV-assessed DOR per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | All Cohorts: INV-assessed CBR per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | All Cohorts: INV-assessed PFS per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | All Cohorts: IRC- and INV-assessed time to central nervous system (CNS) progression per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | All Cohorts: Overall Survival (OS) | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO) | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC) | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: KIRC-assessed DOR per INRC | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed CBR per INRC | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed PFS per INRC | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed ORR per INRC | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed DOR per INRC | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed CBR per INRC | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed PFS per INRC | Approximately up to 12 years | ||
Secondary | All Cohorts: IRC-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive circulating tumor DNA (ctDNA) by blood-based next-generation sequencing (NGS) assay | Approximately up to 12 years | ||
Secondary | All Cohorts: IRC-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay | Approximately up to 12 years | ||
Secondary | All Cohorts: IRC-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay | Approximately up to 12 years | ||
Secondary | All Cohorts: IRC-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay | Approximately up to 12 years | ||
Secondary | All Cohorts: INV-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay | Approximately up to 12 years | ||
Secondary | All Cohorts: INV-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay | Approximately up to 12 years | ||
Secondary | All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay | Approximately up to 12 years | ||
Secondary | All Cohorts: INV-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: IRC-assessed intracranial (IC)-ORR per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS rate per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS rate per RECIST v1.1 | Approximately up to 12 years | ||
Secondary | All Cohorts: Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) | The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points. | Approximately up to 12 years | |
Secondary | All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score | Approximately up to 12 years | ||
Secondary | All Cohorts: Percentage of participants with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the EORTC QLQ-C30 | Approximately up to 12 years | ||
Secondary | All Cohorts: Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library | The EORTC Item library includes stand-alone symptoms scales and an overall assessment of treatment bother to provide additional information not currently captured in the EORTC QLQ-C30. The scales use the same rating scale and recall period of previous week as the symptom scales in the EORTC QLQ-C30. | Approximately up to 12 years | |
Secondary | All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.) | Approximately up to 12 years | |
Secondary | Cohorts A, B: Plasma concentration of entrectinib at specified timepoints | Day 1 of Cycle 1-6 and Day 1 of every other Cycle going forward (one Cycle=28 days) | ||
Secondary | Cohort C: Plasma concentration of alectinib at specified timepoints | Cycle 1, Day 1 and Day 15; Day 1 of Cycle 2-6, and Day 1 of every other Cycle going forward (one Cycle=28 days) | ||
Secondary | Cohort D: Plasma concentration of atezolizumab at specified timepoints | Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days) | ||
Secondary | Cohort E: Plasma concentration of ipatasertib at specified timepoints | Cycle 1, Day 1 and 15; Cycle 2, Day 1; Cycle 3, Day 15; Cycle 4, Day 1, and every even Cycle thereafter (one Cycle=28 days) | ||
Secondary | Cohort F: Serum concentration of trastuzumab emtansine at specified timepoints | Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days) | ||
Secondary | Cohort G: Plasma concentration of idasanutlin at specified timepoint | Cycle 1, Day 1, 2, 5, 8; Cycle 2, Day 1, 2, 5; Cycle 3, Day 2, 5; Cycle 4, Day 1, and every other Cycle going forward (one Cycle=28 days) | ||
Secondary | Cohort H: Plasma concentration of GDC-0077 at specified timepoints | Cycle 1, Day 1, 8 (+/-1 day), 15 (+/-1 day); Cycle 2, Day 1 (+/-1 day); Day 1 of Cycle 4, and every other even Cycle going forward (one Cycle=28 days) | ||
Secondary | Cohort L: Plasma concentration of GDC-6036 at specified timepoints | Cycle 1: Day 1, 15; Cycles 2-5, Day 1, Cycle 7, Day 1 and every other cycle until post 1-year of treatment (Day of Cycles 7, 9, 11) (Cycle=21 days)) | ||
Secondary | Cohort M: Plasma concentration of Camonsertib at specified timepoints | Cycle 1, Day 1, 2, 8; Cycle 2-4, Day 1; Cycle 5, Day 1, and every odd cycle until post 1-year of treatment (Cycles 7, 9, 11, and 13) (Cycle=21 days)) | ||
Secondary | Cohort N: Plasma concentration of Camonsertib at specified timepoints | Cycle 1, Day 1, 2, 8; Cycle 2-4, Day 1; Cycle 5, Day 1, and every odd cycle until post 1-year of treatment (Cycles 7, 9, 11, and 13) (Cycle=21 days)) | ||
Secondary | Cohorts D, F: Percentage of participants with anti-drug antibodies (ADA) | Cohort D: Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days); Cohort F: Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days) |
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Phase 1/Phase 2 | |
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Active, not recruiting |
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Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
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Completed |
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Phase 1/Phase 2 | |
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Phase 1 |