Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 34
- Primary Endpoint
- Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Intervention: RG1507 (Drug)
2
Intervention: RG1507 (Drug)
3
Intervention: RG1507 (Drug)
Outcomes
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)(Throughout study)