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Brief Title: An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies
Official Title: 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
Study ID: NCT01677780
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR