ATRi Transition Rollover Study
- Registration Number
- NCT03309150
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
The main purpose of the study was to monitor the safety of participant receiving long-term treatment of Berzosertib as monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part A1: Berzosertib Berzosertib -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Treatment Related AEs 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Royal Marsden NHS Foundation Trust
🇬🇧Sutton, United Kingdom