Trial · NCT05309668
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Selumetinib AUC0-12 Derived After Single Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8 and 10-12 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days) | To determine the pharmacokinetics of selumetinib after administration of the selumetinib granule formulation |
| Primary | Adverse Events Graded by CTCAE Ver 5.0 | from screening until 30 days after last dose | To assess the safety and tolerability of the selumetinib granule formulation. |
| Secondary | Palatability Using the Parent-reported Observer Palatability Questionnaire | Twice daily (morning and evening), from the first day of study treatment (Cycle 1 Day 1) for one week, from Cycle 7 Day 1 for one week (each cycle is 28 days) | To assess the palatability of the selumetinib granule formulation |
| Secondary | Selumetinib and N-desmethyl Selumetinib AUC0-12 Derived After Single and Multiple Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib and N-desmethyl Selumetinib Cmax Derived After Single and Multiple Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib and N-desmethyl Selumetinib AUC0-6 Derived After Single and Multiple Dose Administration | Pre-dose and 1, 2, 3, 4 and 6 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Objective Response Rate | At screening, at week 17 (Cycle5 Day1), week 33 (Cycle9 Day1), week 49 (Cycle13 Day1), week 73 (Cycle19 Day1) and week 97 (Cycle25 Day1), end of treatment (each cycle is 28 days) | To evaluate the efficacy of the selumetinib granule formulation by assessment of Objective Response Rate |
| Secondary | Selumetinib and N-desmethyl Selumetinib AUClast Derived After Single and Multiple Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib and N-desmethyl Selumetinib Tmax Derived After Single and Multiple Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib and N-desmethyl Selumetinib Tlast Derived After Single and Multiple Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib and N-desmethyl Selumetinib AUC0-24 Derived After Single Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib CL/F Derived After Single Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib Vz/F Derived After Single Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib t1/2λz Derived After Single Dose Administration | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib and N-desmethyl Selumetinib Rac Cmax Derived After Multiple Dose Administration | Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib and N-desmethyl Selumetinib RacAUC0-12 Derived After Multiple Dose Administration | Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib CL/F Derived After Multiple Dose Administration | Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Selumetinib Vss/F Derived After Multiple Dose Administration | Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Parent-to-metabolite Ratio for AUC0-6, AUC0-12 and AUC0-24 After Single and Multiple Dose Administration. | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on Cycle 1 Day 1. Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
| Secondary | Parent to Metabolite Ratio for Cmax After Single and Multiple Dose Administration. | Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days) | To further evaluate the PK of the granule formulation. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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