Myeloproliferative Neoplasms Clinical Trial

Clinical Trial Finder Myeloproliferative Neoplasms Trials

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

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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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Eligibility Criteria

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 is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

11

Study ID:

NCT01677780

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 5 Locations for this study

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Sarcoma Oncology Center
Santa Monica California, 90403, United States
M.D Anderson Cancer Center; Oncology
Houston Texas, 77030, United States
Cancer Therapy & Research Ctr; Dept Institute for Drug Development
San Antonio Texas, 78229, United States
Princess Margaret Hospital, Medical Oncology & Haematology
Toronto Ontario, M5G 2, Canada
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse , 31059, France
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How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

11

Study ID:

NCT01677780

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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