A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms

In brief

This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.

Key facts

Study ID

NCT00559533

Run by

Hoffmann-La Roche

People needed

106

Starts

2007-12-01

Expected to finish

2012-11-01

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;
• solid tumor malignancies;
• failed prior therapies, or no standard therapy available;
• ECOG performance status of 0-2.

You may not qualify if…

• patients receiving any other agent or therapy to treat their malignancy;
• pre-existing gastrointestinal disorders which may interfere with absorption of drugs;
• clinically significant cardiovascular disease.

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Bordeaux, France
• Study site — Lyon, France

Full record on ClinicalTrials.gov

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