A Multiple Ascending Dose Study of R1507 in Children and Adolescents 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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Key information

Conditions

Neoplasms

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RG1507

Drug

3mg/kg iv weekly

Primary outcomes

Serum drug exposure level equivalent to exposure in adults at adult recommended dose.

Time frame: Throughout study

Secondary outcomes

MTD (AEs, laboratory parameters)

Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Nov 19, 2007
Registry last updated: Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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