Protocol #: 18-441
Status
Recruiting
Description
The ATR(ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for the treatment of patients with advanced solid tumors and lymphomas. The purpose of the proposed trial is to evaluate the safety and tolerability of BAY1895344, and to identify the maximum tolerated dose of BAY1895344 that could be safely given to cancer patients. Further, the response of the cancer to the treatment will be determined.
Condition
Neoplasms
Interventions
BAY1895344
Phase
Phase 1
Study Type
Interventional
Further Study Details
Primary Outcome:
The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D) of BAY1895344
Incidence of DLTs during Cycle 1 in dose-escalation cohorts during Part A of the study
Incidence of DLTs during Cycle 1 in dose-escalation cohorts during Part A.1 of the study
Incidence of DLTs during Cycle 1 in dose-escalation cohorts during J-arm of the study
The incidence of serious and nonserious treatment-emergent adverse events (TEAEs)
AUC (area under the plasma concentration of BAY1895344 vs. time curve) from zero to 12 hours after single-dose (C1D1) and multiple-dose administrations (C1D10)
Cmax of BAY1895344 in cycle 1 after single-dose (C1D1) and multiple-dose administrations (C1D10)
Secondary Outcome:
Incidence of patients with CR, PR, SD or PD (except for patients with castration resistant prostate cancer) consistent with the RECIST 1.1 criteria
Incidence of lymphoma patients with CR, PR, SD or PD consistent with the Lugano Classification
Incidence of castration resistant prostate cancer patients with CR, PR, SD or PD consistent with the recommendations of the Prostate Cancer Working Group 3 (PCWG3)
Estimated Enrollment
276
Study Start Date
July 6, 2017
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Bayer
Information Provided By
Bayer
Official Title
An Open-label, First-in-human, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose and / or Recommended Phase II Dose of the ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas
Clinicaltrials.gov Identifier
NCT03188965

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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