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

Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560144
• Other study ID #: NO21200
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2007
• Last updated: October 29, 2016
• Start date: December 2007
• Est. completion date: December 2011

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00557271

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RG1507
3mg/kg iv weekly
• RG1507
9mg/kg iv weekly
• RG1507
Pharmacokinetic-derived dose, <=16mg/kg iv weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum drug exposure level equivalent to exposure in adults at adult recommended dose.		Throughout study	No
Secondary	MTD (AEs, laboratory parameters)		Throughout study	No