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A Multi-Center, Open-Label, Extension Study of RO5045337 (MDM2 Antagonist) Administered Orally in Patients Treated With RO5045337 on Previous Roche-Sponsored Phase 1 Cancer Studies
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Sarcoma Oncology Center
Santa Monica, California, United States
M.D Anderson Cancer Center; Oncology
Houston, Texas, United States
Cancer Therapy & Research Ctr; Dept Institute for Drug Development
San Antonio, Texas, United States
Princess Margaret Hospital, Medical Oncology & Haematology
Toronto, Ontario, Canada
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France
Start Date
November 28, 2012
Primary Completion Date
June 26, 2017
Completion Date
June 26, 2017
Last Updated
July 7, 2017
11
ACTUAL participants
RO5045337
DRUG
Lead Sponsor
Hoffmann-La Roche
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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