Spots Global Cancer Trial Database for A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors
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Trial Identification
Brief Title: A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors
Official Title: Phase II, Exploratory, Multicenter, Non Randomized, Single Agent Cohort Study to Determine Best Tumor Response With Trastuzumab Emtansine in HER2 Overexpressing Solid Tumors
Study ID: NCT02999672
Interventions
Study Description
Brief Summary: This multicenter, non-randomized, Phase II study will assess the efficacy, safety, and pharmacokinetics of trastuzumab emtansine in participants with HER2 overexpressing locally advanced (unresectable and not treatable with curative intent) or metastatic urothelial bladder cancer (UBC), locally advanced (unresectable and not treatable with curative intent) or metastatic pancreatic cancer/cholangiocarcinoma with advanced disease where cure is no longer possible and where no other treatment options are available anymore. Participants will receive intravenous (IV) infusion of trastuzumab emtansine as Regimen A (2.4 milligrams per kilogram \[mg/kg\], weekly \[qw\]) or Regimen B (3.6 mg/kg, every 3 weeks \[q3w\]) until unacceptable toxicity, withdrawal of consent, disease progression (PD), or death, whichever occurs first. Based on tolerability and safety aspects, steering committee and Independent Data Monitoring Committee (iDMC) will decide on expansion of the study to include more participants with other carcinoma types.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
Irccs Ospedale San Raffaele;Oncologia Medica, Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche, Milano, Lombardia, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima, Padova, Veneto, Italy
A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U., Verona, Veneto, Italy
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Amsterdam UMC Location VUMC, Amsterdam, , Netherlands
UMCG, NL -groningen, , Netherlands
Erasmus MC - Centrum, NL -rotterdam, , Netherlands
Narodny onkologicky ustav, Bratislava, , Slovakia
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Hospital Duran i Reynals; Oncologia, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia, Malaga, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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