How was the Saltikva Phase 2 trial designed?

Q: How was the Saltikva Phase 2 trial designed?

The Saltikva Phase 2 ( NCT04589234 ) is an open-label, non-randomized, two-arm study at a single site, the Segal Cancer Centre of the Jewish General Hospital in Montreal, with Gerald Batist, MD and Petr Kavan, MD as principal investigators. It was sponsored by Salspera, Inc.; data were collected by the investigators and an independent monitor (Exactis) and analyzed by the sponsor, with oversight by an independent Data Safety and Monitoring Committee. One arm gave Saltikva with FOLFIRINOX and the other with gemcitabine and nab-paclitaxel; outcomes were compared with same-site historical controls. Expanded-access patients were admitted according to the Expanded Access Program (EAP): they met the trial's formal inclusion criteria, were treated per the FOLFIRINOX arm of the study protocol and were included in the study analysis. The primary endpoints were overall and progression-free survival. The trial was approved by Health Canada and a local ethics board.

Question

Accepted Answer

The Saltikva Phase 2 (NCT04589234) is an open-label, non-randomized, two-arm study at a single site, the Segal Cancer Centre of the Jewish General Hospital in Montreal, with Gerald Batist, MD and Petr Kavan, MD as principal investigators. It was sponsored by Salspera, Inc.; data were collected by the investigators and an independent monitor (Exactis) and analyzed by the sponsor, with oversight by an independent Data Safety and Monitoring Committee. One arm gave Saltikva with FOLFIRINOX and the other with gemcitabine and nab-paclitaxel; outcomes were compared with same-site historical controls. Expanded-access patients were admitted according to the Expanded Access Program (EAP): they met the trial's formal inclusion criteria, were treated per the FOLFIRINOX arm of the study protocol and were included in the study analysis. The primary endpoints were overall and progression-free survival. The trial was approved by Health Canada and a local ethics board.