CompletedPhase 1/2

Trial of Afatinib in Pediatric Tumours

United States, Australia, Austria56 participantsStarted 2015-04-29

Plain-language summary

Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types

Who can participate

Age range1 Year – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Paediatric patients aged 1 year to \<18 years at the time of informed consent * diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation * recurrent/refractory disease after they received at least one prior standard treatment regimen * no effective conventional therapy exists * Performance status \>= 50% (Lansky for =\<12ys; Karnofsky for \>12ys) * Further inclusion criteria apply Exclusion criteria: * relevant toxicity from previous treatment * known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis * Further exclusion criteria apply

What they're measuring

Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort

Timeframe: Assessed every 8 weeks until progression of disease, up to 336 days.

Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part

Timeframe: Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8.

Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part

Timeframe: Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8.

Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part

Timeframe: During the first course (28 days) of treatment.

Trial details

NCT IDNCT02372006

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-05

Results submitted2021-02-04

View on ClinicalTrials.gov More Neuroectodermal Tumors trials

Plain-language summary

Who can participate

Age range1 Year – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort

Timeframe: Assessed every 8 weeks until progression of disease, up to 336 days.

Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part

Timeframe: Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8.

Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part

Timeframe: Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8.

Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part

Timeframe: During the first course (28 days) of treatment.