drugset / Trial / NCT01677780

An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies

NCT01677780 ↗

Phase 1 Completed 11 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This open-label, extension study is designed to provide continuing treatment with RO5045337 to participants who have completed parent studies NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296). Participants are eligible to participate in this study if they have completed required Phase 1 study assessments for primary objectives of respective parent protocol and are having evidence of clinical benefit (as defined by the parent protocol). Participants will continue the most similar dose and formulation available (which does not exceed the maximum tolerated dose \[MTD\] or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from the parent clinical study protocol.

Timeline

Start
2012-11-28
Primary completion
2017-06-26
Completion
2017-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject RO5045337 Small molecule 20 mg/m2 Oral
Subject RO5045337 Small molecule 1500 mg Oral
Subject RO5045337 Small molecule 1800 mg/m2 Oral

Indications