CompletedPhase 1

ATRi Transition Rollover Study

United Kingdom1 participantsStarted 2018-01-10

Plain-language summary

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

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Up to 6 years

Trial details

NCT IDNCT03309150

SponsorMerck KGaA, Darmstadt, Germany

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-26

Results submitted2024-10-14

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