A Study of R547 in Patients With Advanced Solid Tumors.

Completed · Phase 1

Conditions studied: Neoplasms

In brief

This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.

Key facts

Study ID

NCT00400296

Run by

Hoffmann-La Roche

People needed

58

Starts

2005-05-01

Expected to finish

2008-11-01

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;
• locally advanced or metastatic solid tumors;
• measurable or evaluable disease.

You may not qualify if…

• prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study;
• prior history of CNS metastases with disease progression;
• patients taking strong inhibitors and/or inducers of CYP3A4.

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.