Trial information
A Dose-Escalating Study of R7159 Monotherapy in Patients With CD20+ Malignant Disease.
Status: Recruiting
Protocol number: BO21003
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label, dose-escalating study to investigate the safety and tolerability of R7159 monotherapy in patients with CD20+ malignant disease
Brief summary: This study will investigate the safety and tolerability of weekly intravenous R7159 monotherapy, in patients with CD20+ malignant disease. Having identified the recommended dose for further investigation, additional patients with relapsed CD20+ follicular NHL will be randomized to receive either this dose of R7159, or MabThera (rituximab) 375mg/m2, given as weekly infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
180.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Non-Hodgkin's Lymphoma
Intervention type: Drug
Intervention name: R7159
Primary outcome: 1. Phase 1: Incidence of dose-limiting toxicity.
Time frame: Event driven
2. Phase 2: Overall response rate. Time frame: Event driven
Key secondary outcomes: 1. Complete and partial response rates, progression-free survival, event-free survival, duration of response (Phase 2 only) Time frame: Event driven
2. AEs, laboratory parameters, pharmacodynamic and pharmacokinetic parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- part 1 only: CD20+ malignant disease (lymphoma or CLL);
- part 2 only: relapsed CD20+ follicular non-Hodgkin's lymphoma.
Exclusion criteria:
- prior use of any investigational monoclonal antibody within 6 months of study start;
- prior use of any anti-cancer vaccine;
- prior use of MabThera within 8 weeks of study entry;
- CNS lymphoma.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2008
Trial registration date: 12/17/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
Canada
- Calgary, AB
- Vancouver, BC
- Kingston, ON
- London, ON
- Toronto, ON
- Montreal, QC
Italy
- Brescia
- Milano
- Novara
- Pisa
- Torino
Poland
