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

Phase 1

• Conditions: Recurrent or refractory malignant solid tumors in children between 2 and 17 year of age; MedDRA version: 19.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001046-26-Outside-EU/EEA
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-30
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 58

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 58
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified