A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

Condition(s) studied

Investigational drug(s) / intervention(s)

Pirtobrutinib: Administered orally.

Study summary

The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.

Eligibility

Primary outcome measure(s)

• Percentage of Participants with a Grade ≥3 treatment-emergent AEs — Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier

Trial sites (38)

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