CompletedPhase 1

Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Hungary6 participantsStarted 2022-02-15

Plain-language summary

The study was conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study was 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 was to assess safety and efficacy of berzosertib in combination with topotecan.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: . * Histologically proven advanced solid tumors that are considered appropriate for treatment in Period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated * Eastern Cooperative Oncology Group Performance Status (ECOG PS) =\< 1 * Evaluable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Screening * Participant has adequate renal, hematological and hepatic function * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Participants with uncontrolled intercurrent illness including, but not limited to, severe active infection including, acute respiratory syndrome coronavirus-2 infection/coronavirus disease 2019 (Covid 19), immune deficiencies, uncontrolled diabetes, uncontrolled arterial hypertension and symptomatic congestive heart failure * Concurrent participation in another interventional clinical study is not permitted. * Known hypersensitivity to the study interventions, a similar structural compound, or to one or more excipients used * Prior or concurrent treatment with a nonpermitted drug/intervention from the first dose of study intervention administration, as defined per protocol. * Other protocol defined exclusion criteria could apply

What they're measuring

Period 1: Percent Urinary Recovery (Feurine) of Total Radioactivity

Timeframe: Predose, 0-4, 4-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours after dosing on Day 1, continued in 24-hour intervals, until discharge criteria are met, assessed up to Day 14 post-dose

Period 1: Percent Fecal Recovery (Fefeces) of Total Radioactivity

Period 1: Percent Total Recovery in Urine and Feces (Fetotal) of Total Radioactivity

Period 1: Maximum Observed Plasma Concentration (Cmax) of Berzosertib

Timeframe: Predose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours after dosing on Day 1, continued in 24-hour intervals, until discharge criteria are met, assessed up to Day 14 post-dose

Period 1: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Berzosertib

Trial details

NCT IDNCT05246111

SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-28

Results submitted2024-09-25

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