Trial Information

Summary: A Study of R547 in Patients With Advanced Solid Tumors.

Status: No longer recruiting

Protocol Number: NP18378

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A multiple ascending dose (MAD) study of R547 administered as an intravenous infusion on a weekly schedule in patients with advanced solid tumors

Brief Summary: This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals. Target sample size is 57.

Study Phase: I

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety

Study Type:

Condition: Neoplasms

Intervention Type: Drug

Intervention Name: R547

Primary Outcome: 1. AEs, laboratory parameters. Time frame: Throughout study

Key Secondary Outcomes: 1. Pharmacokinetic and pharmacodynamic profiles of R547 Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2005

Trial Registration Date: 11/16/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:28:35 PM