Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors
Status:
Completed
Trial end date:
2019-11-05
Target enrollment:
Participant gender:
Summary
The study design was an open-label Phase II pediatric clinical study. The purpose of Study
X2203 was to identify any efficacy signal in subjects with the disease subtypes under study,
when treated with pazopanib monotherapy. Furthermore, it was to define the toxicities of
pazopanib in children, as well as examine biological markers, e.g. cytokines and angiogenic
factors, that could help further characterize any response of pazopanib in children.
Pazopanib was administered as monotherapy in tablet and powder suspension formulations at
daily doses of 450 mg/m2/dose or 225 mg/m2/dose, respectively. The first 6 enrolled subjects
receiving oral suspension formulation were assessed for tolerability and extended PK
sampling; and, only if pazopanib was tolerated, subsequent subjects were enrolled at the same
starting dose with the suspension. Dose escalation was not permitted. For the tablet, a
dosing nomogram was used based on the subject's BSA. Dose reduction was dependent upon the
toxicity of pazopanib and disease status of the infants, toddlers, children, adolescents, and
young adults. Subjects could be as young as 1 year-old infants to screen for enrollment.
Subjects were assessed for initial response after 8 weeks of treatment prior to Cycle 3. A
cycle was defined as 28 days of pazopanib treatment with no rest period between cycles.
Treatment was administered continuously once daily. Treatment was to be discontinued if there
was evidence of disease progression, unacceptable treatment-related toxicity, pregnancy.
Histological classification was an important diagnostic inclusion in these subjects with a
wide variety of refractory solid tumors, i.e. 7 different tumor types and each being a
cohort.