Trial information
A Study of R7112 in Patients With Advanced Solid Tumors.
Status: Recruiting
Protocol number: NO21280
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to investigate the maximum tolerated dose and different dosing schedules of R7112 in patients with advanced solid tumors
Brief summary: This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of R7112, 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, and the target sample size is <100 individuals. Target sample size is 70.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Neoplasms
Intervention type: Drug
Intervention name: R7112
Primary outcome: 1. MTD and associated dose schedule Time frame: Every 28 days
Key secondary outcomes: 1. Clinical response Time frame: Event driven
2. Dose-limiting toxicities. Time frame: Throughout study
3. Pharmacokinetic profile Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- solid tumor malignancies;
- failed prior therapies, or no standard therapy available;
- ECOG performance status of 0-2.
Exclusion criteria:
- 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2007
Trial registration date: 11/14/2007
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- Aurora, CO
- New York, NY
- Houston, TX
- San Antonio, TX
