Trial information
A Study of R7112 in Patients With Hematologic Neoplasms.
Status: Recruiting
Protocol number: NO21279
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to investigate the maximum tolerated dose of R7112 in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML) in blast phase, or refractory chronic lymphocytic leukemia/small cell lymphocytic lymphoma (CLL / SCLL)
Brief summary: This study will determine the maximum tolerated dose of R7112 and the optimal associated 4 weekly dosing schedule of R7112, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day po, 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 in <100 individuals. Target sample size is
140.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Hematologic Neoplasms
Intervention type: Drug
Intervention name: R7112
Primary outcome: 1. Maximum tolerated dose and associated dose schedule Time frame: Throughout study
Key secondary outcomes: 1. Clinical response. Dose limiting toxicities. Pharmacokinetic profile. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia in blast phase, refractory chronic lymphocytic leukemia/small cell lymphocytic lymphoma;
- relapsed or refractory to approved therapies, or no viable alternative 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
Trial registration date: 02/15/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- Duarte, CA
- New Brunswick, NJ
- Houston, TX
- San Antonio, TX
