Trial Information

Summary: A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.

Status: Recruiting

Protocol Number: NO21200

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: Multiple Ascending Dose (MAD) study of the IGF-1R Antagonist R1507 administered as an intravenous infusion in pediatric patients with advanced solid tumors.

Brief Summary: This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in children and adolescents with advanced solid tumors equivalent to the exposure achieved in adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of patients will be enrolled at the optimal dose/MTD. 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 39.

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. Serum drug exposure level equivalent to exposure in adults at adult recommended dose. Time frame: Throughout study

Key Secondary Outcomes: 1. MTD (AEs, laboratory parameters) Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 2 Years Max: 17 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: November, 2007

Trial Registration Date: 11/16/2007

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: September 22, 2008 at 2:54:32 PM