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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560144
First Posted: November 19, 2007
Last Update Posted: November 1, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Neoplasms Drug: RG1507 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Serum drug exposure level equivalent to exposure in adults at adult recommended dose. [ Time Frame: Throughout study ]

Secondary Outcome Measures:
  • MTD (AEs, laboratory parameters) [ Time Frame: Throughout study ]

Enrollment: 34
Study Start Date: December 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG1507
3mg/kg iv weekly
Experimental: 2 Drug: RG1507
9mg/kg iv weekly
Experimental: 3 Drug: RG1507
Pharmacokinetic-derived dose, <=16mg/kg iv weekly

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560144


Locations
United States, Arizona
Tucson, Arizona, United States, 85724
United States, Colorado
Denver, Colorado, United States, 80218
United States, Maryland
Bethesda, Maryland, United States, 20982
United States, New York
New York, New York, United States, 10017
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560144     History of Changes
Obsolete Identifiers: NCT00557271
Other Study ID Numbers: NO21200
First Submitted: November 16, 2007
First Posted: November 19, 2007
Last Update Posted: November 1, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs