stop_circleTerminated/Withdrawn

Advanced solid tumors (excluding prostate cancer), ovarian cancer

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

All

Age

18 - N/A

Trial summary

Enrollment Goal
14
Trial Dates
February 2020 - December 2023
Phase
Phase 1
Could I Receive a placebo
No
Products
Elimusertib (BAY1895344)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
University of Texas MD Anderson Cancer CenterHouston, 77030, United States
Completed
Memorial Sloan-Kettering Cancer CenterNew York, 10065, United States
Completed
Dana-Farber Cancer InstituteBoston, 02215, United States
Withdrawn
Cleveland Clinic FoundationCleveland, 44195, United States
Withdrawn
Ospedale Regionale di Bellinzona e ValliBellinzona, 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 1
    date_rangeTime Frame:
    Cycle 1, 28 days after first administration of study intervention
  • Recommended Phase II dose (RP2D) of elimusertib
    date_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 administration
    date_rangeTime Frame:
    Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
  • AUC(0-8) of elimusertib after single dose administration
    date_rangeTime Frame:
    Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
  • Cmax,md of elimusertib after multiple dose administration
    date_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 administration
    AUC: Area under the curve
    date_rangeTime Frame:
    Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.

Trial design

An open-label phase 1b study to determine the maximum tolerated and/or recommended phase 2 dose of the ATR inhibitor elimusertib (BAY 1895344) in combination with PARP inhibitor niraparib, in participants with recurrent advanced solid tumors and ovarian cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
6