ATRi Transition Rollover Study

Merck KGaA, Darmstadt, Germany1 enrolled

Overview

The main purpose of the study was to monitor the safety of participant receiving long-term treatment of Berzosertib as monotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Stage Solid Tumors

Interventions

BerzosertibDRUG

Participants received intravenous infusion of Berzosertib at a dose of 126 milligrams (mg) on Days 1, 8 and 15 until disease progression or unacceptable toxicity occurred.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Participants ongoing treatment in Vertex study VX13-970-002. * Participant must be able to understand and provide written informed consent. * Participant must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures. Exclusion Criteria: * Participants experiencing disease progression or unacceptable toxicity at the time of transition into the this study.

Locations (1)

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Treatment Related AEs

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-related AEs: reasonably related to the study intervention.

Time frame: Up to 6 years

Data from ClinicalTrials.gov

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