Status:
COMPLETED
Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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, rate...
Eligibility Criteria
Inclusion
- .
- 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
- 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
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05246111
Start Date
February 15 2022
End Date
June 28 2023
Last Update
November 22 2024
Active Locations (2)
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1
Magyar Honvédség Egészségügyi Központ, Podmaniczky utcai telephely, Onkológiai Osztály
Budapest, Hungary
2
PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, Hungary