Trial Information

Summary: 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 Design / Study Details:

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

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2007

Trial Registration Date: 11/14/2007

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: June 30, 2008 at 3:13:40 PM