Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

February 15, 2022

Primary Completion Date

June 28, 2023

Study Completion Date

June 28, 2023

Conditions
Advanced Solid Tumor
Interventions
DRUG

[14C]Berzosertib

Participants received single intravenous infusion of \[14C\]Berzosertib at a dose of 210 milligrams per square meter (mg/m\^2) 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

Berzosertib

Participants received single intravenous infusion of Berzosertib at a dose of 210 mg/m\^2 on Day 2 and Day 5 in period 2 until disease progression or other criteria for study intervention discontinuation were met.

DRUG

Topotecan

Participants received topotecan at a dose of 1.25 mg/m\^2 intravenously on Days 1 through 5 of each 21-day cycle in period 2 until disease progression or other criteria for study intervention discontinuation were met.

Trial Locations (2)

Unknown

Magyar Honvédség Egészségügyi Központ, Podmaniczky utcai telephely, Onkológiai Osztály, Budapest

PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely, Budapest

All Listed Sponsors
lead

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

INDUSTRY