Clinical Trial: NCT02372006 - My Cancer Genome

NCT02372006

Description:

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

Related Conditions:

Astrocytoma
Diffuse Intrinsic Pontine Glioma
Ependymoma
Malignant Glioma
Malignant Solid Tumor
Medulloblastoma
Neuroblastoma
Primitive Neuroectodermal Tumor
Rhabdomyosarcoma

Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02372006

Trial Eligibility

Document

Title

Brief Title: Trial of Afatinib in Pediatric Tumours
Official Title: Phase I/II Open Label, Dose Escalation Trial to Determine the MTD, Safety, PK and Efficacy of Afatinib Monotherapy in Children Aged ≥1 Year to <18 Years With Recurrent/Refractory Neuroectodermal Tumours, Rhabdomyosarcoma and/or Other Solid Tumours With Known ErbB Pathway Deregulation Regardless of Tumour Histology

Clinical Trial IDs

ORG STUDY ID: 1200.120
SECONDARY ID: 2014-002123-10
NCT ID: NCT02372006

Conditions

Neuroectodermal Tumors
Rhabdomyosarcoma

Interventions

Drug	Synonyms	Arms
afatinib		afatinib

Purpose

Trial Arms

Name	Type	Description	Interventions
afatinib	Experimental	dose escalation	afatinib

Eligibility Criteria

        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

Maximum Eligible Age:	18 Years
Minimum Eligible Age:	1 Year
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort
Time Frame:	Assessed every 8 weeks until progression of disease, up to 336 days.
Safety Issue:
Description:	Number of participants with objective response for maximum tolerated dose expansion (MTD) cohort was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression.

Secondary Outcome Measures

Measure:	Number of Participants With Objective Response - Dose Finding Part
Time Frame:	Assessed every 8 weeks until progression of disease, up to 336 days.
Safety Issue:
Description:	Number of participants with objective response for Dose finding part was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression.

Measure:	Progression Free Survival - Maximum Tolerated Dose (MTD) Expansion Cohort
Time Frame:	From the first treatment until date of first progression or death, up to 336 days.
Safety Issue:
Description:	Progression free survival for the MTD expansion cohorts was reported. Progression free survival (PFS) was defined as the duration from the date of first treatment until the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of last adequate tumour assessment.

Measure:	Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) - Dose Finding Part
Time Frame:	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 on Day 1.
Safety Issue:
Description:	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (AUC0-24) for Dose finding part was reported.

Measure:	Maximum Measured Concentration (Cmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort
Time Frame:	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 on Day 1.
Safety Issue:
Description:	Maximum measured concentration (Cmax) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

Measure:	Time From (Last) Dosing to the Maximum Measured Concentration (Tmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort
Time Frame:	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 on Day 1.
Safety Issue:
Description:	Time from (last) dosing to the maximum measured concentration (tmax) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

Measure:	Time From (Last) Dosing to the Maximum Measured Concentration at Steady State (Tmax,ss) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort
Time Frame:	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.
Safety Issue:
Description:	Time from (last) dosing to the maximum measured concentration at steady state (tmax,ss) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

Measure:	Accumulation (or Effective) Half-life - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort
Time Frame:	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.
Safety Issue:
Description:	Accumulation (or effective) half-life for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

Measure:	Duration of Objective Response - Maximum Tolerated Dose (MTD) Expansion Cohort
Time Frame:	From first documented response until the earliest of disease progression or death, up to 336 days.
Safety Issue:
Description:	Duration of objective response in maximum tolerated dose expansion (MTD) cohort was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression.

Measure:	Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort
Time Frame:	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.
Safety Issue:
Description:	Area under the curve over dosing interval τ at steady state (AUCτ,ss) in maximum tolerated dose (MTD) expansion cohort was reported.

Measure:	Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort
Time Frame:	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.
Safety Issue:
Description:	Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) in maximum tolerated dose (MTD) expansion cohort was reported.

Details

Phase:	Phase 1/Phase 2
Primary Purpose:	Interventional
Overall Status:	Completed
Lead Sponsor:	Boehringer Ingelheim

Last Updated

March 4, 2021

Clinical Trials /

Trial of Afatinib in Pediatric Tumours