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NCT02639546 · OUTCOME

PFS as Determined by the Investigator Using RECIST v1.1 Criteria for Participants With All Other Tumours (Phase I)

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors · Source last updated 2022-09-16

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)

What was measured

Tumor assessment was performed using RECIST v1.1 for Participants with All Other Tumours.

Analysis population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.

Groups in this outcome

Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation

Participants with Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation.

Malignant Peripheral Nerve Sheath Tumor

Participants with Malignant Peripheral Nerve Sheath Tumor.

Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation

Participants with Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation.

Non-Rhabdomyosarcoma Soft Tissue Sarcoma

Participants with Non-Rhabdomyosarcoma Soft Tissue Sarcoma.

Plexiform Neurofibroma

Participants with Plexiform Neurofibroma.

Rhabdoid Tumor/ATRT

Participants with Rhabdoid Tumor/ATRT.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation1
Malignant Peripheral Nerve Sheath Tumor2
Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation1
Non-Rhabdomyosarcoma Soft Tissue Sarcoma1
Plexiform Neurofibroma12
Rhabdoid Tumor/ATRT1

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway ActivationNANot reportedNANAPFS could not be calculated from the data of 1 participant
Malignant Peripheral Nerve Sheath Tumor4.1Not reported0.7NAThe upper limit could not be calculated from the data due to insufficient number of participants with events.
Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation1.1Not reportedNANAThe upper and lower limits could not be calculated from the data of 1 participant.
Non-Rhabdomyosarcoma Soft Tissue Sarcoma3.4Not reportedNANAThe upper and lower limits could not be calculated from the data of 1 participant.
Plexiform NeurofibromaNANot reported18.4NAThe upper limit could not be calculated from the data due to insufficient number of participants with events.
Rhabdoid Tumor/ATRT0.5Not reportedNANAThe upper and lower limits could not be calculated from the data of 1 participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        PFS could not be calculated from the data of 1 participant
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The upper limit could not be calculated from the data due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        0.7
        upper Limit
        NA
        value
        4.1
      3. comment
        The upper and lower limits could not be calculated from the data of 1 participant.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        1.1
      4. comment
        The upper and lower limits could not be calculated from the data of 1 participant.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        3.4
      5. comment
        The upper limit could not be calculated from the data due to insufficient number of participants with events.
        group Id
        OG004
        lower Limit
        18.4
        upper Limit
        NA
        value
        NA
      6. comment
        The upper and lower limits could not be calculated from the data of 1 participant.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        0.5
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      12
    6. group Id
      OG005
      value
      1
    units
    Participants
description
Tumor assessment was performed using RECIST v1.1 for Participants with All Other Tumours.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation.
    id
    OG000
    title
    Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation
  2. description
    Participants with Malignant Peripheral Nerve Sheath Tumor.
    id
    OG001
    title
    Malignant Peripheral Nerve Sheath Tumor
  3. description
    Participants with Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation.
    id
    OG002
    title
    Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation
  4. description
    Participants with Non-Rhabdomyosarcoma Soft Tissue Sarcoma.
    id
    OG003
    title
    Non-Rhabdomyosarcoma Soft Tissue Sarcoma
  5. description
    Participants with Plexiform Neurofibroma.
    id
    OG004
    title
    Plexiform Neurofibroma
  6. description
    Participants with Rhabdoid Tumor/ATRT.
    id
    OG005
    title
    Rhabdoid Tumor/ATRT
param Type
MEDIAN
population Description
The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
reporting Status
POSTED
time Frame
From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)
title
PFS as Determined by the Investigator Using RECIST v1.1 Criteria for Participants With All Other Tumours (Phase I)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice