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

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRO5045337

The study team can explain what participation involves.

Who it may be forMyelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 7, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Hoffmann-La Roche

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Hoffmann-La Roche
Interventions being studied: Drug: RO5045337

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Reasons someone may not be able to joinExclusion criteria

Participants must meet the

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Sarcoma Oncology CenterSanta Monica, California
M.D Anderson Cancer Center; OncologyHouston, Texas
Cancer Therapy & Research Ctr; Dept Institute for Drug DevelopmentSan Antonio, Texas
Princess Margaret Hospital, Medical Oncology & HaematologyToronto, Ontario
Institut Claudius Regaud; Departement Oncologie MedicaleToulouse

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 7, 2017. Always confirm current availability with the study team.

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