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CompletedNCT02372006Updated Mar 4, 2021Results posted

Trial of Afatinib in Pediatric Tumours

A Phase 1/2 interventional study of afatinib in Neuroectodermal Tumors and Rhabdomyosarcoma, sponsored by Boehringer Ingelheim. Completed at 28 sites in 12 countries. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2021-03-04.

Sponsored by Boehringer Ingelheim · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
1 Year to 18 Years
Sex
All
01

Study 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
02

Conditions studied

  • Neuroectodermal Tumors
  • Rhabdomyosarcoma
03

In context

Neuroectodermal Tumors

29 studies on the registry are indexed under Neuroectodermal Tumors; 6 are open to participants now.

This study's enrollment of 56 is above the median of 37 across 21 interventional studies indexed under Neuroectodermal Tumors.

Browse Neuroectodermal Tumors studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Paediatric patients aged 1 year to \<18 years at the time of
  • diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation
  • recurrent/ disease after they received at least one prior standard treatment regimen
  • no effective conventional therapy exists
  • Performance status >= 50% (Lansky for =\<12ys; for >12ys)
  • Further inclusion criteria apply

Exclusion criteria

Exclusion criteria:

  • relevant toxicity from previous treatment
  • known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis
  • Further exclusion criteria apply
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    afatinib

    dose escalation

    Drug: afatinib

Interventions

06

What researchers measure

Primary outcomes

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

    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.

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

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

    Area under the curve over dosing interval τ at steady state (AUCτ,ss) for Dose finding part was reported.

    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.

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

    Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for Dose finding part was reported.

    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.

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

    Number of participants with Dose Limiting Toxicity adverse events for Dose finding part was reported.

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

Secondary outcomes

  1. Number of Participants With Objective Response - Dose Finding Part

    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.

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

  2. Progression Free Survival - Maximum Tolerated Dose (MTD) Expansion Cohort

    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.

    Time frame: From the first treatment until date of first progression or death, up to 336 days.

  3. 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

    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.

    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.

  4. Maximum Measured Concentration (Cmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort

    Maximum measured concentration (Cmax) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

    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.

  5. Time From (Last) Dosing to the Maximum Measured Concentration (Tmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort

    Time from (last) dosing to the maximum measured concentration (tmax) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

    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.

  6. Time From (Last) Dosing to the Maximum Measured Concentration at Steady State (Tmax,ss) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort

    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.

    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.

  7. Accumulation (or Effective) Half-life - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort

    Accumulation (or effective) half-life for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

    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.

  8. Duration of Objective Response - Maximum Tolerated Dose (MTD) Expansion Cohort

    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.

    Time frame: From first documented response until the earliest of disease progression or death, up to 336 days.

  9. Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort

    Area under the curve over dosing interval τ at steady state (AUCτ,ss) in maximum tolerated dose (MTD) expansion cohort was reported.

    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.

  10. Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort

    Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) in maximum tolerated dose (MTD) expansion cohort was reported.

    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.

07

Results

Posted Mar 4, 2021

Participant flow

Phase I/II open label, dose escalation trial to determine the Maximum tolerated dose (MTD), safety, Pharmacokinetics (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.

Participant flow — Overall Study
MilestoneDose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Started8939
Completed000
Not completed8939
Withdrew: Progressive disease8734
Withdrew: Dose limiting toxicity010
Withdrew: Adverse event003
Withdrew: Withdrawal by subject011
Withdrew: Other reason for not completing001

Outcome measures

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

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.

Time frame:
Assessed every 8 weeks until progression of disease, up to 336 days.
Reported as:
Count of participants · Participants
Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort
ParticipantsMaximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort3
PrimaryArea Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part

Area under the curve over dosing interval τ at steady state (AUCτ,ss) for Dose finding part was reported.

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.
Reported as:
Geometric mean · hours times nanogram per milliliter
Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part
hours times nanogram per milliliterDose Finding - Level 0Dose Finding - Level 1
Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part681 ± 43.81380 ± 29.0
PrimaryMaximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part

Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for Dose finding part was reported.

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.
Reported as:
Geometric mean · nanogram per mililiter
Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part
nanogram per mililiterDose Finding - Level 0Dose Finding - Level 1
Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part53.0 ± 48.8115 ± 39.3
PrimaryNumber of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part

Number of participants with Dose Limiting Toxicity adverse events for Dose finding part was reported.

Time frame:
During the first course (28 days) of treatment.
Reported as:
Count of participants · Participants
Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part
ParticipantsDose Finding - Level 0Dose Finding - Level 1
Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part12
SecondaryNumber of Participants With Objective Response - Dose Finding Part

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.

Time frame:
Assessed every 8 weeks until progression of disease, up to 336 days.
Reported as:
Count of participants · Participants
Number of Participants With Objective Response - Dose Finding Part
ParticipantsDose Finding - Level 0Dose Finding - Level 1
Number of Participants With Objective Response - Dose Finding Part00
SecondaryProgression Free Survival - Maximum Tolerated Dose (MTD) Expansion Cohort

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.

Time frame:
From the first treatment until date of first progression or death, up to 336 days.
Reported as:
Median · Months
Progression Free Survival - Maximum Tolerated Dose (MTD) Expansion Cohort
MonthsMaximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Progression Free Survival - Maximum Tolerated Dose (MTD) Expansion Cohort8.0 (6.4 to 8.29)
SecondaryArea Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) - Dose Finding Part

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.

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.
Reported as:
Geometric mean · hours times nanogram per mililiter
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
hours times nanogram per mililiterDose Finding - Level 0Dose Finding - Level 1
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) - Dose Finding Part383 ± 46.4512 ± 40.6
SecondaryMaximum Measured Concentration (Cmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort

Maximum measured concentration (Cmax) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

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.
Reported as:
Geometric mean · nanogram per mililiter
Maximum Measured Concentration (Cmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort
nanogram per mililiterDose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Maximum Measured Concentration (Cmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort36.4 ± 55.943.8 ± 61.230.5 ± 90.3
SecondaryTime From (Last) Dosing to the Maximum Measured Concentration (Tmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort

Time from (last) dosing to the maximum measured concentration (tmax) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

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.
Reported as:
Median · Hours
Time From (Last) Dosing to the Maximum Measured Concentration (Tmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort
HoursDose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Time From (Last) Dosing to the Maximum Measured Concentration (Tmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort3.02 (2.00 to 6.00)3.43 (2.00 to 6.02)3.98 (1.00 to 8.00)
SecondaryTime From (Last) Dosing to the Maximum Measured Concentration at Steady State (Tmax,ss) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort

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.

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.
Reported as:
Median · Hours
Time From (Last) Dosing to the Maximum Measured Concentration at Steady State (Tmax,ss) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort
HoursDose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Time From (Last) Dosing to the Maximum Measured Concentration at Steady State (Tmax,ss) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort3.00 (2.00 to 6.00)2.75 (2.00 to 5.05)4.17 (2.00 to 8.00)
SecondaryAccumulation (or Effective) Half-life - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort

Accumulation (or effective) half-life for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.

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.
Reported as:
Geometric mean · hours
Accumulation (or Effective) Half-life - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort
hoursDose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Accumulation (or Effective) Half-life - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort18.7 ± 44.331.0 ± 56.730.3 ± 83.6
SecondaryDuration of Objective Response - Maximum Tolerated Dose (MTD) Expansion Cohort

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.

Time frame:
From first documented response until the earliest of disease progression or death, up to 336 days.
Reported as:
Median · Days
Duration of Objective Response - Maximum Tolerated Dose (MTD) Expansion Cohort
DaysMaximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Duration of Objective Response - Maximum Tolerated Dose (MTD) Expansion Cohort62 (57 to 170)
SecondaryArea Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort

Area under the curve over dosing interval τ at steady state (AUCτ,ss) in maximum tolerated dose (MTD) expansion cohort was reported.

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.
Reported as:
Geometric mean · hours times nanogram per milliliter
Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort
hours times nanogram per milliliterMaximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort780 ± 60.7
SecondaryMaximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort

Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) in maximum tolerated dose (MTD) expansion cohort was reported.

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.
Reported as:
Geometric mean · nanogram per mililiter
Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort
nanogram per mililiterMaximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Maximum Tolerated Dose (MTD) Expansion Cohort52.5 ± 61.0

Adverse events

Collected over From the first drug administration until end of study, up to 336 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dose Finding - Level 08/8 (100%)7/8 (87.5%)8/8 (100%)
Dose Finding - Level 19/9 (100%)6/9 (66.7%)9/9 (100%)
Maximum Tolerated Dose (MTD) Expansion Cohort - Level 029/39 (74.4%)20/39 (51.3%)38/39 (97.4%)
Most frequent serious events
Showing 10 of 40
Most frequent serious events
EventDose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
VomitingGastrointestinal disorders3/82/92/39
HeadacheNervous system disorders3/81/90/39
DiarrhoeaGastrointestinal disorders0/83/90/39
Decreased appetiteMetabolism and nutrition disorders0/82/90/39
BlindnessEye disorders1/80/90/39
Abdominal painGastrointestinal disorders1/80/90/39
General physical health deteriorationGeneral disorders1/80/90/39
PyrexiaGeneral disorders1/81/92/39
Gastroenteritis viralInfections and infestations1/80/91/39
HemiparesisNervous system disorders1/80/91/39
Most frequent other events
Showing 10 of 124
Most frequent other events
EventDose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
DiarrhoeaGastrointestinal disorders6/86/930/39
ConstipationGastrointestinal disorders6/81/94/39
VomitingGastrointestinal disorders3/86/916/39
Abdominal painGastrointestinal disorders4/82/98/39
FatigueGeneral disorders4/81/910/39
EpistaxisRespiratory, thoracic and mediastinal disorders4/81/97/39
Dry skinSkin and subcutaneous tissue disorders2/84/910/39
NauseaGastrointestinal disorders1/82/915/39
AnaemiaBlood and lymphatic system disorders3/81/97/39
Dry eyeEye disorders3/80/93/39

Baseline characteristics

Treated set (TS) This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.

Age, Continuous
Age, Continuous(Years)Dose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0Total
Mean9.75 ± 4.8310.44 ± 5.2910.92 ± 4.4410.68 ± 4.57
Sex: Female, Male
Sex: Female, Male(Participants)Dose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0Total
Female441624
Male452332
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Dose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0Total
Hispanic or Latino0000
Not Hispanic or Latino453746
Unknown or Not Reported44210
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dose Finding - Level 0Dose Finding - Level 1Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0Total
American Indian or Alaska Native0000
Asian0011
Native Hawaiian or Other Pacific Islander0000
Black or African American0022
White342936
More than one race1001
Unknown or Not Reported45716
08

Study locations

28 sites
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • University of Wisconsin
    Madison, Wisconsin 53792, United States
  • Sydney Childrens Hospital
    Randwick, New South Wales 2031, Australia
  • AKH - Medical University of Vienna
    Vienna, 1090, Austria
  • St. Anna Children-Hospital, Children's Cancer Research, Wien
    Wien, 1090, Austria
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
  • Rigshospitalet, København, Børneonkologisk Afsnit 5002
    København Ø, 2100, Denmark
  • HOP Toulouse, Pédiat, Toulouse
    Toulouse, 31059, Faroe Islands
  • HOP Pellegrin
    Bordeaux, 33076, France
  • CTR Oscar Lambret
    Lille, 59020, France
  • CTR Leon Berard
    Lyon, 69008, France
  • INS Curie
    Paris, 75248, France
  • INS Gustave Roussy
    Villejuif, 94805, France
  • Charité - Universitätsmedizin Berlin
    Berlin, 13353, Germany
  • Universitätsklinikum Essen AöR
    Essen, 45147, Germany
  • Universitätsklinikum Tübingen
    Tübingen, 72076, Germany
  • Istituto G. Gaslini
    Genova, 16147, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori
    Milano, 20133, Italy
  • Azienda Ospedaliera Universitaria di Padova
    Padova, 35128, Italy
  • Osp. Pediatrico Bambin Gesù
    Roma, 00165, Italy
  • Erasmus MC - Sophia Kinderziekenhuis
    Rotterdam, 3015 CN, Netherlands
  • Hospital Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Infantil Universitario Niño Jesus
    Madrid, 28009, Spain
  • Birmingham Children's Hospital
    Birmingham, B4 6NH, United Kingdom
  • Great Ormond Street Hospital
    London, WC1N 3BN, United Kingdom
  • Royal Manchester Children's Hospital
    Manchester, M13 9WL, United Kingdom
  • The Royal Marsden Hospital
    Sutton, SM2 5PT, United Kingdom
09

References and documents

Publications

  • Andrade RC, Boroni M, Amazonas MK, Vargas FR. New drug candidates for osteosarcoma: Drug repurposing based on gene expression signature. Comput Biol Med. 2021 Jul;134:104470. doi: 10.1016/j.compbiomed.2021.104470. Epub 2021 May 7. PubMed 34004576 ↗

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2015 to primary completion in Aug 2020, 63 months.

Results were first posted in Mar 2021, 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2015
First posted
Feb 26, 2015
StartActual
Apr 29, 2015
Primary completionActual
Aug 5, 2020
CompletionActual
Aug 5, 2020
Results first posted
Mar 4, 2021
Last update
Mar 4, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02372006
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Feb 26, 2015
Start date
Apr 29, 2015
Primary completion
Aug 5, 2020
Completion
Aug 5, 2020
Results posted
Mar 4, 2021
Last update
Mar 4, 2021

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Afatinib

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Other studies from this sponsor

Boehringer Ingelheim →

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