Spots Global Cancer Trial Database for Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)
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Trial Identification
Brief Title: Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)
Official Title: Phase I Study to Evaluate the Mass Balance, PK, Metabolism and Excretion of Berzosertib (Intravenous) Containing Microtracer [14C]Berzosertib in Participants With Advanced Solid Tumors (DDRiver Solid Tumors 208)
Study ID: NCT05246111
Conditions
Study Description
Brief Summary: The study will be conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study is to provide a quantitative characterization of the mass balance, rates and routes of elimination, and metabolic pathways after a single intravenous administration of \[14C\]berzosertib. The purpose of Period 2 is to assess safety and efficacy of berzosertib in combination with topotecan.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Magyar Honvédség Egészségügyi Központ, Podmaniczky utcai telephely, Onkológiai Osztály, Budapest, , Hungary
PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely, Budapest, , Hungary
Contact Details
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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