Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: M6620, [14C]M6620 and Topotecan
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Drug: [14C]M6620
Participants will receive single intravenous infusion of [14C]M6620 on Day 1 in Period 1 and stay in clinical research unit (CRU) is required until the discharge criteria are met with a maximum confinement period of 15 days.
Drug: M6620
Participants will receive intravenous infusion of M6620 on Day 2 and Day 5 of each 21-day cycle in period 2 until disease progression or other criteria for study intervention discontinuation are met.
Other Names:
Drug: Topotecan
Participants will receive intravenous infusion of topotecan on Day 1 through Day 5 of each 21-day cycle in period 2 until disease progression or other criteria for study intervention discontinuation are met.
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Outcome Measures
Primary Outcome Measures
- Period 1: Percent Urinary Recovery (feurine) of Total Radioactivity [Pre-dose until discharge criteria are met, assessed up to 14 days post-dose]
- Period 1: Percent Fecal Recovery (fefeces) of Total Radioactivity [Pre-dose until discharge criteria are met, assessed up to 14 days post-dose]
- Period 1: Percent Total Recovery in Urine and Feces (fetotal) of Total Radioactivity [Pre-dose until discharge criteria are met, assessed up to 14 days post-dose]
- Period 1: Pharmacokinetic (PK) Plasma and Urine Concentration of M6620 [Pre-dose until discharge criteria are met, assessed up to 14 days post-dose]
- Period 1: Pharmacokinetic Plasma and Blood Concentration of Total Radioactivity [Pre-dose until discharge criteria are met, assessed up to 14 days post-dose]
Secondary Outcome Measures
- Period 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events [Period 1: Baseline up to Day 14; Period 2: From Day 1 of period 2 until disease progression or other criteria for study intervention discontinuation are met (up to a maximum of approximately 14 months)]
Eligibility Criteria
Criteria
Inclusion Criteria: .
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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
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Eastern Cooperative Oncology Group Performance Status (ECOG PS) =< 1
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Evaluable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Screening
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Participant has adequate renal, hematological and hepatic function
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Other protocol defined inclusion criteria could apply
Exclusion Criteria:
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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
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Concurrent participation in another interventional clinical study is not permitted.
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Known hypersensitivity to the study interventions, a similar structural compound, or to one or more excipients used
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Prior or concurrent treatment with a nonpermitted drug/intervention from the first dose of study intervention administration, as defined per protocol.
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Other protocol defined exclusion criteria could apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Magyar Honvédség Egészségügyi Központ, Podmaniczky utcai telephely, Onkológiai Osztály | Budapest | Hungary | 1062 | |
2 | PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely | Budapest | Hungary | 1077 |
Sponsors and Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Investigators
- Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MS201923_0008
- 2021-002226-24