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

NCT01677780 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-07-07

No results posted yet for this study

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.

Conditions

  • Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

Interventions

DRUG

RO5045337

Participants will receive RO5045337 orally in doses ranging from 20 milligram per square meter (mg/m\^2) to 1800 mg/m\^2 daily, and up to 1500 mg dose twice daily on a variety of schedules including daily for up to 20 days and weekly dosing for 3 weeks in 28 day cycles until disease progression or unacceptable toxicity with maximum treatment duration of 24 months.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States
  • Canada
  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677780 on ClinicalTrials.gov