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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00560144
First received: November 16, 2007
Last updated: August 4, 2014
Last verified: August 2014

November 16, 2007
August 4, 2014
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 ] [ 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
Not Provided
Not Provided
 
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 t he exposure achieved in adults at the recommended dose of 9mg/kg/week. It will a lso determine the maximum tolerated dose (if appropriate) and the pharmacokineti c profile of R1507. Groups of patients will be sequentially enrolled in one of u p to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1 507 administered weekly by intravenous infusion.An expanded cohort of patients w ill 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 s ize is <100 individuals.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
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.
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00560144
NO21200
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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