A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Reference Study ID Number: GO42144 whttps://forpatients.roche.com/ Kontakt: Phone: 888-662-6728 (U.S. and Canada) E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen
Studienlocations (3 von 75)
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden 01307 Dresden (Sachsen) GermanyZurückgezogen» Google-MapsCity of Hope Comprehensive Cancer Center 91010 Duarte United StatesRekrutierend» Google-MapsUCSD Moores Cancer Center 92093 La Jolla United StatesRekrutierend» Google-Maps
Chao Family Comprehensive Cancer Center UCI 92868 Orange United StatesRekrutierend» Google-MapsUniv of Calif, San Francisco; Breast Cancer Center 94115 San Francisco United StatesZurückgezogen» Google-MapsYale Cancer Center 06520 New Haven United StatesRekrutierend» Google-MapsFlorida Cancer Specialists - Sarasota 34232 Sarasota United StatesRekrutierend» Google-MapsDana Farber Cancer Institute 02215 Boston United StatesRekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center 11101 New York United StatesRekrutierend» Google-MapsUniversity of Oklahoma; Stephenson Oklahoma Canc Ctr 73104 Oklahoma City United StatesRekrutierend» Google-MapsAbramson Cancer Center; Univ of Pennsylvania 19104 Philadelphia United StatesRekrutierend» Google-MapsUPMC - Hillman Cancer Center 15232 Pittsburgh United StatesRekrutierend» Google-MapsSt Vincent's Hospital Sydney 2010 Darlinghurst AustraliaRekrutierend» Google-MapsSlade Health Inward goods 2080 Mount Kuring-gai AustraliaRekrutierend» Google-MapsAlfred Health 3004 Melbourne AustraliaRekrutierend» Google-MapsPeter MacCallum Cancer Center 3051 North Melbourne AustraliaRekrutierend» Google-MapsLinear Clinical Research Limited 6009 Nedlands AustraliaRekrutierend» Google-MapsUZ Antwerpen 2650 Edegem BelgiumRekrutierend» Google-MapsCHU de Liège 4000 Liège BelgiumRekrutierend» Google-MapsAZ St Maarten Campus Leopoldstr 2800 Mechelen BelgiumAktiv, nicht rekrutierend» Google-MapsSanta Casa de Misericordia de Belo Horizonte - PPDS 30150-221 Belo Horizonte BrazilRekrutierend» Google-MapsHospital de Clinicas de Porto Alegre HCPA PPDS 90035-903 Porto Alegre BrazilRekrutierend» Google-MapsHospital Erasto Gaertner 81520-060 Curitiba BrazilRekrutierend» Google-MapsInstituto Nacional de Câncer 20230-130 Rio de Janeiro BrazilRekrutierend» Google-MapsUniversidade de Caxias do Sul 95070-561 Caxias Do Sul BrazilRekrutierend» Google-MapsHospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) 90610-000 Porto Alegre BrazilRekrutierend» Google-MapsHospital de Cancer de Barretos 14784-400 Barretos BrazilRekrutierend» Google-MapsFundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS 15090-000 Sao Jose Do Rio Preto BrazilRekrutierend» Google-MapsInstituto do Cancer do Estado de Sao Paulo - ICESP 01246-000 Sao Paulo BrazilRekrutierend» Google-MapsOttawa Hospital K1H 8L6 Ottawa CanadaRekrutierend» Google-MapsPrincess Margaret Cancer Centre M5G 1Z5 Toronto CanadaRekrutierend» Google-MapsJewish General Hospital; Sir Mortimer B. Davis H2W 1S6 Montreal CanadaRekrutierend» Google-MapsSemmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika 1088 Budapest HungaryZurückgezogen» Google-MapsClinexpert Kft. - Gyongyos 3200 Gyongyos HungaryRekrutierend» Google-MapsRambam Medical Center 3109601 Haifa IsraelRekrutierend» Google-MapsSheba Medical Center - PPDS 5266202 Ramat Gan IsraelRekrutierend» Google-MapsTel-Aviv Sourasky Medical Center 6423906 Tel Aviv IsraelRekrutierend» Google-MapsIstituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS 47014 Meldola ItalyAbgeschlossen» Google-MapsIrccs Ospedale San Raffaele;Oncologia Medica 20132 Milano ItalyRekrutierend» Google-MapsAsst Grande Ospedale Metropolitano Niguarda 20162 Milano ItalyRekrutierend» Google-MapsIstituto Clinico Humanitas 20089 Rozzano (MI) ItalyRekrutierend» Google-MapsAzienda Ospedaliero Universitaria Pisana 56126 Pisa ItalyRekrutierend» Google-MapsAga Khan University Hospital 00100 Nairobi KenyaRekrutierend» Google-MapsSeoul National University Bundang Hospital 463-707 Seongnam-si Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center - PPDS 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center - PPDS 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsHet Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis 1066 CX Amsterdam NetherlandsRekrutierend» Google-MapsLeids Universitair Medisch Centrum 2333 ZA Leiden NetherlandsRekrutierend» Google-MapsMaastricht University Medical Center 6229 HX Maastricht NetherlandsRekrutierend» Google-MapsUniversitair Medisch Centrum Utrecht 3584 CX Utrecht NetherlandsRekrutierend» Google-MapsAuckland City Hospital, Cancer and Blood Research 1023 Auckland New ZealandRekrutierend» Google-MapsAuckland City Hospital 1023 Auckland New ZealandRekrutierend» Google-MapsNew Zealand Clinical Research - Christchurch 8011 Christchurch New ZealandRekrutierend» Google-MapsHaukeland University Hospital; Hospital Pharmacy 5053 Bergen NorwayRekrutierend» Google-MapsOslo university hospital Radiumhospitalet 0424 Oslo NorwayRekrutierend» Google-MapsMedical University of Gdansk 80-952 Gdansk PolandRekrutierend» Google-MapsBiokinetica, Przychodnia Jozefow 05-410 Jozefow PolandRekrutierend» Google-MapsUniwersytecki Szpital Kliniczny w Poznaniu 60-780 Pozna? PolandRekrutierend» Google-MapsRepublican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic 420029 Kazan Russian FederationZurückgezogen» Google-MapsHospital Universitari Vall d'Hebron 08035 Barcelona SpainRekrutierend» Google-MapsSTART Madrid-FJD, Hospital Fundacion Jimenez Diaz 28040 Madrid SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsHospital Universitario HM Sanchinarro-CIOCC 28050 Madrid SpainRekrutierend» Google-MapsHospital Clinico Universitario Virgen de la Victoria 29010 Malaga SpainRekrutierend» Google-MapsHospital Universitario Virgen del Rocío 41013 Sevilla SpainRekrutierend» Google-MapsHospital Clinico Universitario de Valencia 46010 Valencia SpainRekrutierend» Google-MapsUniversitaetsspital Basel; Onkologie 4031 Basel SwitzerlandZurückgezogen» Google-MapsInselspital 3010 Bern SwitzerlandRekrutierend» Google-MapsHôpitaux Universitaires de Genève 1211 Genève SwitzerlandRekrutierend» Google-MapsUnversitätsspital Zürich 8091 Zürich SwitzerlandZurückgezogen» Google-MapsQueen Elizabeth Hospital B15 2TH Birmingham United KingdomRekrutierend» Google-MapsVelindre Cancer Centre CF14 2TL Cardiff United KingdomRekrutierend» Google-MapsUniversity College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility W1T 7HA London United KingdomRekrutierend» Google-MapsThe Christie NHS Foundation Trust M20 4BX Manchester United KingdomRekrutierend» Google-Maps
1. Percentage of Participants With Adverse Events (AEs) (Time Frame - From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.): Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
2. Percentage of Participants With Dose-Limiting Toxicities (DLTs) (Time Frame - From Cycle 1 Day 1 through Day 21. A cycle is 21 days.)
Secondary outcome:
1. Plasma Concentrations of GDC-6036 (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
2. Plasma Concentrations of Erlotinib (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
3. Plasma Concentrations of GDC-1971 (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
4. Plasma Concentrations of Inavolisib (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
5. Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (Time Frame - Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
6. Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 (Time Frame - Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
7. Progression-free survival (PFS) as determined by the investigator according to RECIST v1.1 (Time Frame - Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
8. Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax]) (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
9. Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax]) (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
10. Relationship Between GDC-6036 Exposure (Half-life [t1/2]) (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
11. Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC]) (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
12. Relationship Between Tumor Pharmacodynamic Effects of GDC-6036 (Time Frame - Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.)
Experimental: Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II) Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached.
Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.
Experimental: Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II) Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab.
Experimental: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II) Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.
Experimental: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II) Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.
Experimental: Arm E: GDC-6036 + Erlotinib (Stage I and Stage II) Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib.
Experimental: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II) Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I.
Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II.
Experimental: Arm G: GDC-6036 + Inavolisib (Stage I and Stage II) Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I.
Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II.
GDC-6036: The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation).
Atezolizumab: A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
Cetuximab: Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m^2) IV infusion followed by 250 mg/m^2 IV infusion weekly in 21 day cycles.
Bevacizumab: A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
Erlotinib: 150 mg of erlotinib will be administered PO QD in 21 day cycles.
GDC-1971: The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
Inavolisib: The starting dose of inavolisib will be determined from its single-agent dose escalation.
Quelle: ClinicalTrials.gov
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