A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Tolerability and Pharmacokinetics of Selumetinib after Multiple Doses in Adolescent Children with Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)

Conditions

Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)

Brief summary

Geometric mean ratio of selumetinib AUC0-12, SS for T1 (fed) versus T2 (fasted)

Detailed description

Geometric mean ratio of selumetinib AUC0-12, SS for T3 (fed) versus T2 (fasted), Gastrointestinal AEs graded by CTCAE Version 5.0, Gastrointestinal toxicity diary incorporating the mBSFS-C and Nausea and Vomiting Symptom Rating Scale (adapted from the Children’s Cancer and Leukaemia Group), Usage of GI concomitant medication, Safety and tolerability will be evaluated in terms of AEs, clinical safety laboratory assessments (clinical chemistry, haematology, urinalysis), physical examination, weight, vital signs, ECG, ECHO or cardiac MRI, ophthalmologic assessment and performance status, Assessments related to AEs will include: occurrence/frequency; relationship to study intervention; CTCAE grade; seriousness; death; AEs leading to discontinuation of study intervention; AEs of special interest, Plasma concentrations and PK parameters of selumetinib and N-desmethyl selumetinib after multiple dose administration, including, but not limited to: Cmax, AUClast, tmax, tlast

Related papers

No related papers found yet.

Interventions

DRUGKoselugo 25 mg hard capsules

DRUGKoselugo 10 mg hard capsules

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Geometric mean ratio of selumetinib AUC0-12, SS for T1 (fed) versus T2 (fasted)	—

Secondary

Measure	Time frame
Geometric mean ratio of selumetinib AUC0-12, SS for T3 (fed) versus T2 (fasted), Gastrointestinal AEs graded by CTCAE Version 5.0, Gastrointestinal toxicity diary incorporating the mBSFS-C and Nausea and Vomiting Symptom Rating Scale (adapted from the Children’s Cancer and Leukaemia Group), Usage of GI concomitant medication, Safety and tolerability will be evaluated in terms of AEs, clinical safety laboratory assessments (clinical chemistry, haematology, urinalysis), physical examination, weight, vital signs, ECG, ECHO or cardiac MRI, ophthalmologic assessment and performance status, Assessments related to AEs will include: occurrence/frequency; relationship to study intervention; CTCAE grade; seriousness; death; AEs leading to discontinuation of study intervention; AEs of special interest, Plasma concentrations and PK parameters of selumetinib and N-desmethyl selumetinib after multiple dose administration, including, but not limited to: Cmax, AUClast, tmax, tlast	—

Measure

Time frame

Geometric mean ratio of selumetinib AUC0-12, SS for T3 (fed) versus T2 (fasted), Gastrointestinal AEs graded by CTCAE Version 5.0, Gastrointestinal toxicity diary incorporating the mBSFS-C and Nausea and Vomiting Symptom Rating Scale (adapted from the Children’s Cancer and Leukaemia Group), Usage of GI concomitant medication, Safety and tolerability will be evaluated in terms of AEs, clinical safety laboratory assessments (clinical chemistry, haematology, urinalysis), physical examination, weight, vital signs, ECG, ECHO or cardiac MRI, ophthalmologic assessment and performance status, Assessments related to AEs will include: occurrence/frequency; relationship to study intervention; CTCAE grade; seriousness; death; AEs leading to discontinuation of study intervention; AEs of special interest, Plasma concentrations and PK parameters of selumetinib and N-desmethyl selumetinib after multiple dose administration, including, but not limited to: Cmax, AUClast, tmax, tlast

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Countries

Poland

Outcome results

None listed