Phase 1
Completed N=1
ATRi Transition Rollover Study
Advanced Stage Solid Tumors
Source: ClinicalTrials.gov NCT03309150 ↗
Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Treatment Related AEs — 1; 0 Participants
Summary
The main purpose of the study was to monitor the safety of participant receiving long-term treatment of Berzosertib as monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Treatment Related AEs |
1; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03309150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.