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
  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 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.


Condition Intervention Phase
Neoplasms
Drug: RG1507
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MTD (AEs, laboratory parameters) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 10065
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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560144     History of Changes
Obsolete Identifiers: NCT00557271
Other Study ID Numbers: NO21200
Study First Received: November 16, 2007
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014