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NCT02372006 · FLOW

Participant flow

Trial of Afatinib in Pediatric Tumours · Source last updated 2021-03-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    id
    FG000
    title
    Dose Finding - Level 0
  2. description
    Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    id
    FG001
    title
    Dose Finding - Level 1
  3. description
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    id
    FG002
    title
    Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        34
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Dose limiting toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Other reason for not completing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        39
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
recruitment Details
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.
Complete source fields
groups
  1. description
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    id
    FG000
    title
    Dose Finding - Level 0
  2. description
    Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    id
    FG001
    title
    Dose Finding - Level 1
  3. description
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    id
    FG002
    title
    Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        34
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Dose limiting toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Other reason for not completing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        39
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
recruitment Details
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.

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Preserved source evidence · Not medical advice