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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00560144

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: RG1507 Drug: RG1507 Drug: RG1507	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

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.

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Serum drug exposure level equivalent to exposure in adults at adult recommended dose. [Throughout study]

Secondary Outcome Measures

MTD (AEs, laboratory parameters) [Throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Tucson	Arizona	United States	85724
2	Denver	Colorado	United States	80218
3	Bethesda	Maryland	United States	20982
4	New York	New York	United States	10017
5	Philadelphia	Pennsylvania	United States	19104
6	Houston	Texas	United States	77030

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00560144

Other Study ID Numbers:

NO21200
NCT00557271

First Posted:

Nov 19, 2007

Last Update Posted:

Nov 1, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Antibodies, Monoclonal

Study Results

No Results Posted as of Nov 1, 2016