Trial Information

Summary: A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.

Status: Recruiting

Protocol Number: BO19373

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A dose-escalation study of R1507 in patients with advanced solid tumors.

Brief Summary: This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. 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 93.

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: R1507

Primary Outcome: 1. AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life Time frame: Throughout study

Key Secondary Outcomes: 1. Tumor response Time frame: Event driven

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: April, 2006

Trial Registration Date: 11/16/2006

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:20:54 PM