A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

Completed · Phase 1

Conditions studied: Sarcoma

In brief

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.

Key facts

Study ID

NCT01605526

Run by

Hoffmann-La Roche

People needed

23

Starts

2012-05-01

Expected to finish

2013-06-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, >/= 18 years of age
• Histologically or cytologically confirmed soft tissue sarcoma
• Evaluable disease according to RECIST version 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
• Eligible for doxorubicin therapy
• Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade </= 1 prior to start of study
• Adequate bone marrow, hepatic and renal function
• Patients with stable CNS metastases are eligible

You may not qualify if…

• Previous treatment with limiting doses of doxorubicin
• Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment </= 28 days from Day 1 dosing on study treatment
• History of seizure disorders or unstable CNS metastases
• Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
• Pregnant or breastfeeding women
• HIV positive patients who are currently receiving combination anti-retroviral therapy
• Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
• Patients receiving oral or parenteral anti-coagulants/anti-platelet agents

Where it is running

• Study site — Santa Monica, California, United States
• Study site — Boston, Massachusetts, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Bordeaux, France
• Study site — Lyon, France
• Study site — Toulouse, France
• Study site — Villejuif, France

Full record on ClinicalTrials.gov

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