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

NCT00560144 | Completed Phase 1

• 1 other identifier: NO21200
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

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

  Throughout study

Secondary Outcomes (1)

• MTD (AEs, laboratory parameters)

  Throughout study

Study Arms (3)

1

EXPERIMENTAL

Drug: RG1507

2

EXPERIMENTAL

Drug: RG1507

3

EXPERIMENTAL

Drug: RG1507

Interventions

RG1507 DRUG

3mg/kg iv weekly

1

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Tucson, Arizona, 85724, United States

Location

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

Bethesda, Maryland, 20982, United States

Location

Unknown Facility

New York, New York, 10017, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

RG-1507 monoclonal antibody

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

US (6)