ATRi Transition Rollover Study | Clinical Trial

Key information

Conditions

Advanced Stage Solid Tumors Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Berzosertib

Drug

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.

Other names: M6620

Primary outcomes

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

Time frame: Up to 6 years

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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

A Rollover Study to Provide Continued Treatment With M6620

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Oct 13, 2017
Registry last updated: Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed