stop_circleTerminated/Withdrawn
Advanced solid tumors (excluding prostate cancer), ovarian cancer
Bayer Identifier:
18595
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
ATR inhibitor elimusertib (BAY1895344) plus niraparib phase 1b study in advanced solid tumors and ovarian cancer
Trial purpose
The purpose of the study is to test how well patients with advanced solid tumors and ovarian cancer respond to treatment with elimusertib in combination with niraparib. In addition researchers want to find for patients the optimal dose of elimusertib in combination with niraparib, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug. The study medication elimusertib works by blocking a substance produced by the body (ATR Kinase) which is important for the growth of tumor cells. Niraparib works by blocking a substance produced by the body (PARP enzymes) in a way that tumor cells can be killed, or made more susceptible to chemotherapy.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
14Trial Dates
February 2020 - December 2023Phase
Phase 1Could I Receive a placebo
NoProducts
Elimusertib (BAY1895344)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Completed | Dana-Farber Cancer Institute | Boston, 02215, United States |
Withdrawn | Cleveland Clinic Foundation | Cleveland, 44195, United States |
Withdrawn | Ospedale Regionale di Bellinzona e Valli | Bellinzona, 6500, Switzerland |
Primary Outcome
- Incidence of treatment emergent adverse events (TEAEs)date_rangeTime Frame:Up to 30 days after the last administration of study intervention
- Severity of treatment emergent adverse events (TEAEs)date_rangeTime Frame:Up to 30 days after the last administration of study intervention
- Incidence of treatment emergent serious adverse events (TESAEs)date_rangeTime Frame:Up to 30 days after the last administration of study intervention
- Severity of treatment emergent serious adverse events (TESAEs)date_rangeTime Frame:Up to 30 days after the last administration of study intervention
- Maximum tolerated dose (MTD): Frequency of Dose Limiting Toxicities (DLTs) at each dose level during the DLT observation period for Cycle 1date_rangeTime Frame:Cycle 1, 28 days after first administration of study intervention
- Recommended Phase II dose (RP2D) of elimusertibdate_rangeTime Frame:Up to 30 days after last administration of study Intervention
Secondary Outcome
- Incidence of participants with complete response (CR)date_rangeTime Frame:At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
- Incidence of participants with partial response (PR)date_rangeTime Frame:At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
- Incidence of participants with stable disease (SD)date_rangeTime Frame:At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
- Incidence of participants with progressive disease (PD)date_rangeTime Frame:At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
- Objective response rate (ORR)date_rangeTime Frame:At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
- Disease control rate (DCR)date_rangeTime Frame:At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
- Cmax (Maximal plasma exposure) of elimusertib after single dose administrationdate_rangeTime Frame:Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
- AUC(0-8) of elimusertib after single dose administrationdate_rangeTime Frame:Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
- Cmax,md of elimusertib after multiple dose administrationdate_rangeTime Frame:Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
- AUC(0-8)md of elimusertib after multiple dose administrationAUC: Area under the curvedate_rangeTime Frame:Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
6