Trial information
A Study of R547 in Patients With Advanced Solid Tumors.
Status: No longer recruiting
Protocol number: NP18378
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A multiple ascending dose (MAD) study of R547 administered as an intravenous infusion on a weekly schedule in patients with advanced solid tumors
Brief summary: 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. Target sample size is
57.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Neoplasms
Intervention type: Drug
Intervention name: R547
Primary outcome: 1. AEs, laboratory parameters. Time frame: Throughout study
Key secondary outcomes: 1. Pharmacokinetic and pharmacodynamic profiles of R547 Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- locally advanced or metastatic solid tumors;
- measurable or evaluable disease.
Exclusion criteria:
- 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2005
Trial registration date: 11/16/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Aurora, CO
- New Brunswick, NJ
- Charlotte, NC
- Houston, TX
