A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.

Completed · Phase 1

Conditions studied: Neoplasms

In brief

This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.

Key facts

Study ID

NCT00532090

Run by

Hoffmann-La Roche

People needed

110

Starts

2007-11-01

Expected to finish

2010-08-01

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;
• advanced and/or metastatic solid tumor malignancy;
• measurable or evaluable disease;
• ECOG performance status 0 or 1.

You may not qualify if…

• prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
• prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
• major surgery within 28 days of first receipt of study drug.

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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