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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00560144
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : November 1, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

November 16, 2007
November 19, 2007
November 1, 2016
December 2007
December 2011   (Final data collection date for primary outcome measure)
Serum drug exposure level equivalent to exposure in adults at adult recommended dose. [ Time Frame: Throughout study ]
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 Archive Site
MTD (AEs, laboratory parameters) [ Time Frame: Throughout study ]
Efficacy: Tumor response
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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.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: RG1507
    3mg/kg iv weekly
  • Drug: RG1507
    9mg/kg iv weekly
  • Drug: RG1507
    Pharmacokinetic-derived dose, <=16mg/kg iv weekly
  • Experimental: 1
    Intervention: Drug: RG1507
  • Experimental: 2
    Intervention: Drug: RG1507
  • Experimental: 3
    Intervention: Drug: RG1507
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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December 2011
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2016

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