ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Bayer
Study ID
NCT04267939
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elimusertib (BAY1895344) — DRUG
    Elimusertib will be administered in 28-day cycles.
  • Niraparib — DRUG
    Niraparib will be administered in 28-day cycles.

Study Details

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 Dates

Start date
Feb 26, 2020
Status verified
Dec 2023
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Dose escalation of elimusertib_Part A.1
    Dose escalation will initiate with Part A.1 in which niraparib is used at a lower fixed dose.
  • Experimental: Dose escalation of elimusertib_Part A.2
    If the starting dose level in Part A.1 is tolerated, dose escalation in Part A.2 may be initiated on an optional basis. In Part A.2, niraparib is used at a higher fixed dose.
  • Experimental: Dose expansion_sub-population 1_lower dose of niraparib
    MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a lower fixed dose. MTD: Maximum tolerated dose. RP2D: Recommended phase 2 dose.
  • Experimental: Dose expansion_sub-population 2_lower dose of niraparib
    MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a lower fixed dose.
  • Experimental: Dose expansion_sub-population 1_higher dose of niraparib
    MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a higher fixed dose.
  • Experimental: Dose expansion_sub-population 2_higher dose of niraparib
    MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a higher fixed dose.

Primary Outcome Measure

Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 30 days after the last administration of study intervention ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Boston, MA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Dana-Farber Cancer Institute· Boston, MAMemorial Sloan-Kettering Cancer Center· New York, NYUniversity of Texas MD Anderson Cancer Center· Houston, TX

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