Trials / Completed
CompletedNCT02372006
Trial of Afatinib in Pediatric Tumours
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | afatinib |
Timeline
- Start date
- 2015-04-29
- Primary completion
- 2020-08-05
- Completion
- 2020-08-05
- First posted
- 2015-02-26
- Last updated
- 2021-03-04
- Results posted
- 2021-03-04
Locations
28 sites across 12 countries: United States, Australia, Austria, Canada, Denmark, Faroe Islands, France, Germany, Italy, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02372006. Inclusion in this directory is not an endorsement.