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Trial of Afatinib in Pediatric Tumours

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ClinicalTrials.gov Identifier: NCT02372006
Recruitment Status : Recruiting
First Posted : February 26, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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

Condition or disease Intervention/treatment Phase
Neuroectodermal Tumors Rhabdomyosarcoma Drug: afatinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 29, 2015
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020


Arm Intervention/treatment
Experimental: afatinib
dose escalation
Drug: afatinib



Primary Outcome Measures :
  1. Objective response - expansion part/Phase II part [ Time Frame: up to 2 years ]
  2. Dose Limiting Toxicity during first course - dose finding part [ Time Frame: up to 1 year ]
  3. Pharmacokinetics: AUCtau,ss - dose finding part [ Time Frame: up to 1 year ]
  4. Pharmacokinetics: Cmax,ss - dose finding part [ Time Frame: up to 1 year ]

Secondary Outcome Measures :
  1. Pharmacokinetics: tmax,ss - dose finding part [ Time Frame: up to 2 years ]
  2. Pharmacokinetics: Cmax- dose finding part [ Time Frame: up to 2 years ]
  3. Pharmacokinetics: accumulation (or effective) half-life - expansion part/Phase II part [ Time Frame: up to 2 years ]
  4. Objective response - dose finding part [ Time Frame: up to 2 year ]
  5. Progression-free survival - expansion part/Phase II part [ Time Frame: up to 2 years ]
  6. Pharmacokinetics: AUC 0-24 - dose finding part [ Time Frame: up to 24 hours ]
  7. Duration of objective response (DoR) - expansion part/Phase II part [ Time Frame: up to 2 years ]
  8. Pharmacokinetics: accumulation (or effective) half-life - dose finding part [ Time Frame: up to 2 years ]
  9. Pharmacokinetics: AUCtau,ss expansion part/Phase II part [ Time Frame: up to 2 years ]
  10. Pharmacokinetics: Cmax,ss- expansion part/Phase II part [ Time Frame: up to 2 years ]
  11. Pharmacokinetics: tmax ,ss- expansion part/Phase II part [ Time Frame: up to 2 years ]


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372006


Contacts
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Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02372006     History of Changes
Other Study ID Numbers: 1200.120
2014-002123-10 ( EudraCT Number )
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Rhabdomyosarcoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action