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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00560144

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 I

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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:	Disclosures Group, 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:	January 17, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012