Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 02/15/2008

Date Last Updated: 07/15/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: July 21, 2008 at 3:19:50 PM