JoAl Mayor, PharmD, BCOP Study Director Seagen Inc.
Kontakt
Seagen Trial Information Support Kontakt: Phone: 866-333-7436 E-Mail: clinicaltrials@seagen.com» Kontaktdaten anzeigen
Studienlocations (3 von 18)
Charite Universitatsmedizin Berlin 10117 Berlin (Berlin) GermanyRekrutierend» Google-MapsUniversity of Colorado Hospital / University of Colorado 80045 Aurora United StatesRekrutierend» Google-Maps Ansprechpartner: Brandi Asheim E-Mail: brandi.asheim@cuanschutz.edu» Ansprechpartner anzeigenSarah Cannon Research Institute at HealthONE - Denver 80218 Denver United StatesRekrutierend» Google-Maps
AdventHealth Cancer Institute 34747 Celebration United StatesRekrutierend» Google-Maps Ansprechpartner: Charmaine Garcia Phone: 407-303-4471 E-Mail: charmaine.garcia@adventhealth.com» Ansprechpartner anzeigenMayo Clinic Florida 32224 Jacksonville United StatesRekrutierend» Google-Maps Ansprechpartner: Ivy Vilches Phone: 904-953-7844 E-Mail: Vilches.ivyanne@mayo.edu» Ansprechpartner anzeigenFlorida Cancer Specialists - Lake Nona 32827 Orlando United StatesRekrutierend» Google-Maps Ansprechpartner: Elizabeth Griffith Phone: 689-216-8500 E-Mail: Elizabeth.Griffith@scri.com» Ansprechpartner anzeigenNorthwestern University 60611 Chicago United StatesRekrutierend» Google-Maps Ansprechpartner: Northwestern University CT.Gov Contact Phone: 312-695-1301» Ansprechpartner anzeigenCommunity Health Network 46250 Indianapolis United StatesRekrutierend» Google-Maps Ansprechpartner: Adam Byers E-Mail: abyers2@ecommunity.com» Ansprechpartner anzeigenSouth Texas Accelerated Research Therapeutics Midwest 49546 Grand Rapids United StatesRekrutierend» Google-Maps Ansprechpartner: Shannon Fabrie Phone: 616-954-5559» Ansprechpartner anzeigenTennessee Oncology-Nashville/Sarah Cannon Research Institute 37203 Nashville United StatesRekrutierend» Google-Maps Ansprechpartner: Melanie Hurst Phone: 615-979-9868» Ansprechpartner anzeigenMD Anderson Cancer Center / University of Texas 77030 Houston United StatesRekrutierend» Google-Maps Ansprechpartner: Amanda Drews Phone: 832-834-1573» Ansprechpartner anzeigenSouth Texas Accelerated Research Therapeutics 78229 San Antonio United StatesRekrutierend» Google-Maps Ansprechpartner: Isabel Jimenez Phone: 210-593-5265 E-Mail: isabel.jimenez@startsa.com» Ansprechpartner anzeigenSouth Texas Accelerated Research Therapeutics Mountain Region 84119 West Valley City United StatesRekrutierend» Google-Maps Ansprechpartner: Casey Larsen Phone: 801-907-4752» Ansprechpartner anzeigenUniversity of Ottawa / Ottawa General Hospital K1H 8L6 Ottawa CanadaRekrutierend» Google-MapsInstituto Europeo di Oncologia 20132 Milano ItalyRekrutierend» Google-MapsHospital Universitari Vall d'Hebron 08035 Barcelona SpainRekrutierend» Google-MapsSTART Madrid-CIOCC_Hospital HM Sanchinarro 28050 Madrid SpainRekrutierend» Google-MapsSarah Cannon Research Institute UK W1G 6AD London United KingdomRekrutierend» Google-Maps
1. Number of participants with adverse events (AEs) (Time Frame - Through 30 days after last study treatment, up to approximately 3 years): Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
2. Number of participants with laboratory abnormalities (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years)
3. Number of participants with dose limiting toxicities (DLTs) (Time Frame - Up to 28 days)
Secondary outcome:
1. Confirmed objective response rate (ORR) by investigator assessment (Time Frame - Up to approximately 3 years): The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator.
2. Complete response rate (CRR) (Time Frame - Up to approximately 3 years): The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.
3. Duration of response (DOR) (Time Frame - Up to approximately 3 years): The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.
4. Progression-free survival (PFS) (Time Frame - Up to approximately 3 years): The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
5. Overall survival (OS) (Time Frame - Up to approximately 3 years): The time from the start of any study treatment to the date of death due to any cause.
6. Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Time Frame - Through 30-37 days after last study treatment; up to approximately 3 years): To be summarized using descriptive statistics.
7. PK parameter - Maximum concentration (Cmax) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years): To be summarized using descriptive statistics.
8. PK parameter - Time to maximum concentration (Tmax) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years): To be summarized using descriptive statistics.
9. PK parameter - Apparent terminal half-life (t1/2) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years): To be summarized using descriptive statistics.
10. PK parameter - Trough concentration (Ctrough) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years): To be summarized using descriptive statistics.
11. Incidence of antidrug antibodies (ADAs) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years): To be summarized using descriptive statistics.