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Trial of Afatinib in Pediatric Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372006
Recruitment Status : Suspended
First Posted : February 26, 2015
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE February 24, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE April 29, 2015
Estimated Primary Completion Date April 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • Objective response - expansion part/Phase II part [ Time Frame: up to 2 years ]
  • Dose Limiting Toxicity during first course - dose finding part [ Time Frame: up to 1 year ]
  • Pharmacokinetics: AUCtau,ss - dose finding part [ Time Frame: up to 1 year ]
  • Pharmacokinetics: Cmax,ss - dose finding part [ Time Frame: up to 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • Objective response - expansion part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: tmax - dose finding part [ Time Frame: up to 1 year ]
  • Pharmacokinetics: accumulation (or effective) half-live - dose finding part [ Time Frame: up to 1 year ]
  • Dose Limiting Toxicity during first course - dose finding part [ Time Frame: up to 1 year ]
  • Pharmacokinetics: AUC - dose finding part [ Time Frame: up to 1 year ]
  • Pharmacokinetics: Cmax - dose finding part [ Time Frame: up to 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • Pharmacokinetics: tmax,ss - dose finding part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: Cmax- dose finding part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: accumulation (or effective) half-life - expansion part/Phase II part [ Time Frame: up to 2 years ]
  • Objective response - dose finding part [ Time Frame: up to 2 year ]
  • Progression-free survival - expansion part/Phase II part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: AUC 0-24 - dose finding part [ Time Frame: up to 24 hours ]
  • Duration of objective response (DoR) - expansion part/Phase II part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: accumulation (or effective) half-life - dose finding part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: AUCtau,ss expansion part/Phase II part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: Cmax,ss- expansion part/Phase II part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: tmax ,ss- expansion part/Phase II part [ Time Frame: up to 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • Pharmacokinetics: tmax - expansion part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: Cmax- expansion part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: accumulation (or effective) half-live - expansion part [ Time Frame: up to 2 years ]
  • Objective response - dose finding part [ Time Frame: up to 2 year ]
  • Progression-free survival - expansion part [ Time Frame: up to 2 years ]
  • Pharmacokinetics: AUC - expansion part [ Time Frame: up to 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Afatinib in Pediatric Tumours
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuroectodermal Tumors
  • Rhabdomyosarcoma
Intervention  ICMJE Drug: afatinib
Study Arms  ICMJE Experimental: afatinib
dose escalation
Intervention: Drug: afatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Enrollment  ICMJE Not Provided
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2015)
60
Estimated Study Completion Date  ICMJE April 22, 2020
Estimated Primary Completion Date April 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Denmark,   Faroe Islands,   France,   Germany,   Ireland,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries El Salvador
 
Administrative Information
NCT Number  ICMJE NCT02372006
Other Study ID Numbers  ICMJE 1200.120
2014-002123-10 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP