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

Phase 1

Completed

• Conditions: Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute
• Interventions: Drug: RO5045337

• Registration Number: NCT01677780
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-09-03
• Study Start: 2012-11-28
• Primary Completion: 2017-06-26
• Study Completion: 2017-06-26
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Participants must meet the inclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)
• Participants must have completed one of the following clinical study protocols and have been determined to have clinical benefit on treatment at the conclusion of required study analyses as defined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)

Exclusion Criteria

• Participants must meet the exclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)
• Participants who developed disease progression/ requiring other anti-tumor therapy while in the parent protocol
• Participants who have stopped study drug dosing for greater than 56 days
• Participants continuing to require dose modifications
• Participants with worsening adverse events
• Participants with unrelated adverse events, medical illnesses, or changes in performance status that, per investigator discretion, put them at high risk for continuing participation in the clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RO5045337	RO5045337	Participants will continue the most similar dose and formulation available (which does not exceed the 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 their respective parent clinical study protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Approximately 24 months

Trial Locations

Locations (5)

Princess Margaret Hospital, Medical Oncology & Haematology; 🇨🇦 Toronto, Ontario, Canada

Sarcoma Oncology Center; 🇺🇸 Santa Monica, California, United States

Cancer Therapy & Research Ctr; Dept Institute for Drug Development; 🇺🇸 San Antonio, Texas, United States

M.D Anderson Cancer Center; Oncology; 🇺🇸 Houston, Texas, United States

Institut Claudius Regaud; Departement Oncologie Medicale; 🇫🇷 Toulouse, France