A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP) …

This document is intended to explain to responsible parties the process for submitting a good cause extension (GCE) request to extend the deadline for submitting clinical trial results …

Protocol GR41987 has been amended to include aFinalEnd of Study visit, and extend the study to Week 108 for patients who receive their final dose of faricimab at Week 104, and to make …

Patients who have the last injection interval with no DA of q16w in the core study should be injected at another q16w interval before start to extend intervals in the extension study. The …

CONFIDENTIAL This clinical study is being sponsored globally by F. Hoffmann-La Roche Ltd of Basel, Switzerland. However, it may be implemented in individual countries by Roche’s local …

pants with the opportunity to extend treatment with gantenerumab beyond 2 years, thereby providing more information on the long-term safety, tolerability, and efficacy of gantenerumab …

Es/SAEs. The plan is to extend the trial if data support the safety and efficacy endpoints during the 56-week LTE study 4 visit. The M20-186 study team will become unblinded after the M19 …

Declaration of Investigator I have read and understood all sections of the protocol entitled “A Phase 3, Randomized, Double-Blind, Two-Phase, Multicenter Study to Evaluate the Efficacy …

ment #2, the ACNS0332 protocol has been amended to discontinue enrollment of PNET patients and to extend enrollment of medulloblastoma patients to 300 eligible and evaluable patients. …

Extend the adverse event (AE) collection period and contraception requirement duration from 16 weeks after the last dose of study drug to 20 weeks after the last dose of study drug.