Clinical trial · Interventional
ATRi Transition Rollover Study
A Rollover Study to Provide Continued Treatment With M6620
NCT03309150CI-TRIAL-00083155completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of the study was to monitor the safety of participant receiving long-term treatment of Berzosertib as monotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Stage Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Berzosertib | Drug | Berzosertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Part A1: Berzosertib
- interventionNames
- Drug: Berzosertib
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events (AEs) and Treatment Related AEs
- timeFrame
- Up to 6 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.