Spots Global Cancer Trial Database for A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
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Trial Identification
Brief Title: A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
Official Title: A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
Study ID: NCT01605526
Conditions
Study Description
Brief Summary: This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Santa Monica, California, United States
, Boston, Massachusetts, United States
, Hackensack, New Jersey, United States
, Philadelphia, Pennsylvania, United States
, Salt Lake City, Utah, United States
, Bordeaux, , France
, Lyon, , France
, Toulouse, , France
, Villejuif, , France
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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