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A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
This study is ongoing, but not recruiting participants.
Study NCT00560144   Information provided by Hoffmann-La Roche
First Received: November 16, 2007   Last Updated: November 17, 2009   History of Changes

November 16, 2007
November 17, 2009
December 2007
 
Serum drug exposure level equivalent to exposure in adults at adult recommended dose. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Pharmacokinetics: Serum drug exposure level (AUC)equivalent to exposure in adults at adult recommended dose. Safety: Maximum tolerated dose (AEs, lab tests).
Complete list of historical versions of study NCT00560144 on ClinicalTrials.gov Archive Site
MTD (AEs, laboratory parameters) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Tumor response
 
A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.

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.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Neoplasms
Drug: R1507
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
39
October 2011
 

Inclusion Criteria:

  • pediatric patients aged 2-17 years of age;
  • histologically confirmed solid tumors;
  • cancer which has relapsed after, or failed to respond to, curative therapy, or no other potentially curative treatment options available.

Exclusion Criteria:

  • treatment with corticosteroids within past 2 weeks;
  • current or past use of anti-IGF-1R antibodies;
  • current treatment with immunosuppressive agents;
  • patients with diabetes mellitus;
  • known HIV or hepatitis B or C;
  • hypersensitivity to any of the components of R1507 or to monoclonal antibodies.
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00560144
Disclosures Group, Hoffmann-La Roche
NO21200
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP