A Phase 1 interventional study of RG1507 and RG1507 in Neoplasms, sponsored by Hoffmann-La Roche. Completed at 6 sites in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-11-01.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
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.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RG1507
Drug: RG1507
Drug: RG1507
3mg/kg iv weekly
9mg/kg iv weekly
Pharmacokinetic-derived dose, \<=16mg/kg iv weekly
Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
Time frame: Throughout study
MTD (AEs, laboratory parameters)
Time frame: Throughout study
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche