drugset / Trial / NCT02913443

A Dose Finding and Expansion Study of RO7051790 Administered Orally in Participants With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC)

NCT02913443

Phase 1 Completed 18 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase I, open-label, multicenter study designed to assess the safety and tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and expansion study plans to determine the maximum tolerated dose and/or optimal biological dose as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability, pharmacokinetic and pharmacodynamic profiles observed after oral administration of RO7051790.

Timeline

Start
2016-12-20
Primary completion
2017-10-24
Completion
2017-10-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Iadademstat Small molecule 400 ug Oral
Subject Iadademstat Small molecule 1000 ug Oral
Subject Iadademstat Small molecule 1300 ug Oral
Subject Iadademstat Small molecule 1900 ug Oral