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NCT02639546 · OUTCOME

Percentage of Participants With Objective Response (CR or PR) 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Baseline up to 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 Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation0Not reportedNot reportedNot reportedNot reported
Malignant Peripheral Nerve Sheath Tumor0Not reportedNot reportedNot reportedNot reported
Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation0Not reportedNot reportedNot reportedNot reported
Non-Rhabdomyosarcoma Soft Tissue Sarcoma0Not reportedNot reportedNot reportedNot reported
Plexiform Neurofibroma0Not reportedNot reportedNot reportedNot reported
Rhabdoid Tumor/ATRT0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
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.
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
NUMBER
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
Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)
title
Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 Criteria for Participants With All Other Tumours (Phase I)
type
PRIMARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice