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NCT02034110 · OUTCOME

All Collected Deaths

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers · Source last updated 2023-08-21

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
On-treatment deaths: Up to 85 months. Post-treatment survival follow-up deaths: Up to 92 months.

What was measured

On-treatment deaths were collected from first dose of study medication to 30 days after study drug discontinuation, for a maximum duration of 85 months. Post-treatment survival follow-up deaths were collected from day 31 after last dose of first dose of study medication, up to 92 months. All deaths refer to the sum of on-treatment deaths and post-treatment survival follow-up deaths.

Analysis population: All-treated Subjects (ATS) population - Primary and expansion cohort combined

Groups in this outcome

Anaplastic Thyroid Cancer (ATC)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

Biliary Tract Cancer (BTC)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

Gastrointestinal Stromal Tumor (GIST)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

Low Grade (WHO G1/G2) Glioma (LGG)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

High Grade (WHO G3/G4) Glioma (HGG)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

Adenocarcinoma of the Small Intestine (ASI)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

Hairy Cell Leukemia (HCL)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

Multiple Myeloma (MM)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

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

Analysis denominator · Participants

GroupSource count
Anaplastic Thyroid Cancer (ATC)36
Biliary Tract Cancer (BTC)43
Gastrointestinal Stromal Tumor (GIST)1
Low Grade (WHO G1/G2) Glioma (LGG)13
High Grade (WHO G3/G4) Glioma (HGG)45
Adenocarcinoma of the Small Intestine (ASI)3
Hairy Cell Leukemia (HCL)55
Multiple Myeloma (MM)10

Reported measurements

On-treatment deaths

Analysis denominator · Participants

GroupSource count
Anaplastic Thyroid Cancer (ATC)36
Biliary Tract Cancer (BTC)43
Gastrointestinal Stromal Tumor (GIST)1
Low Grade (WHO G1/G2) Glioma (LGG)13
High Grade (WHO G3/G4) Glioma (HGG)45
Adenocarcinoma of the Small Intestine (ASI)3
Hairy Cell Leukemia (HCL)55
Multiple Myeloma (MM)10
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anaplastic Thyroid Cancer (ATC)6Not reportedNot reportedNot reportedNot reported
Biliary Tract Cancer (BTC)6Not reportedNot reportedNot reportedNot reported
Gastrointestinal Stromal Tumor (GIST)0Not reportedNot reportedNot reportedNot reported
Low Grade (WHO G1/G2) Glioma (LGG)1Not reportedNot reportedNot reportedNot reported
High Grade (WHO G3/G4) Glioma (HGG)2Not reportedNot reportedNot reportedNot reported
Adenocarcinoma of the Small Intestine (ASI)0Not reportedNot reportedNot reportedNot reported
Hairy Cell Leukemia (HCL)4Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM)1Not reportedNot reportedNot reportedNot reported
Post-treatment survival follow-up deaths

Analysis denominator · Participants

GroupSource count
Anaplastic Thyroid Cancer (ATC)30
Biliary Tract Cancer (BTC)37
Gastrointestinal Stromal Tumor (GIST)1
Low Grade (WHO G1/G2) Glioma (LGG)12
High Grade (WHO G3/G4) Glioma (HGG)43
Adenocarcinoma of the Small Intestine (ASI)3
Hairy Cell Leukemia (HCL)51
Multiple Myeloma (MM)9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anaplastic Thyroid Cancer (ATC)18Not reportedNot reportedNot reportedNot reported
Biliary Tract Cancer (BTC)28Not reportedNot reportedNot reportedNot reported
Gastrointestinal Stromal Tumor (GIST)1Not reportedNot reportedNot reportedNot reported
Low Grade (WHO G1/G2) Glioma (LGG)3Not reportedNot reportedNot reportedNot reported
High Grade (WHO G3/G4) Glioma (HGG)26Not reportedNot reportedNot reportedNot reported
Adenocarcinoma of the Small Intestine (ASI)3Not reportedNot reportedNot reportedNot reported
Hairy Cell Leukemia (HCL)4Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM)8Not reportedNot reportedNot reportedNot reported
All deaths

Analysis denominator · Participants

GroupSource count
Anaplastic Thyroid Cancer (ATC)36
Biliary Tract Cancer (BTC)43
Gastrointestinal Stromal Tumor (GIST)1
Low Grade (WHO G1/G2) Glioma (LGG)13
High Grade (WHO G3/G4) Glioma (HGG)45
Adenocarcinoma of the Small Intestine (ASI)3
Hairy Cell Leukemia (HCL)55
Multiple Myeloma (MM)10
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anaplastic Thyroid Cancer (ATC)24Not reportedNot reportedNot reportedNot reported
Biliary Tract Cancer (BTC)34Not reportedNot reportedNot reportedNot reported
Gastrointestinal Stromal Tumor (GIST)1Not reportedNot reportedNot reportedNot reported
Low Grade (WHO G1/G2) Glioma (LGG)4Not reportedNot reportedNot reportedNot reported
High Grade (WHO G3/G4) Glioma (HGG)28Not reportedNot reportedNot reportedNot reported
Adenocarcinoma of the Small Intestine (ASI)3Not reportedNot reportedNot reportedNot reported
Hairy Cell Leukemia (HCL)8Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        43
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        45
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        55
      8. group Id
        OG007
        value
        10
      units
      Participants
    title
    On-treatment deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        28
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        26
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        43
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        51
      8. group Id
        OG007
        value
        9
      units
      Participants
    title
    Post-treatment survival follow-up deaths
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        34
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        28
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        8
      8. group Id
        OG007
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        43
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        45
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        55
      8. group Id
        OG007
        value
        10
      units
      Participants
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      43
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      13
    5. group Id
      OG004
      value
      45
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      55
    8. group Id
      OG007
      value
      10
    units
    Participants
description
On-treatment deaths were collected from first dose of study medication to 30 days after study drug discontinuation, for a maximum duration of 85 months. Post-treatment survival follow-up deaths were collected from day 31 after last dose of first dose of study medication, up to 92 months. All deaths refer to the sum of on-treatment deaths and post-treatment survival follow-up deaths.
groups
  1. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG000
    title
    Anaplastic Thyroid Cancer (ATC)
  2. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG001
    title
    Biliary Tract Cancer (BTC)
  3. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG002
    title
    Gastrointestinal Stromal Tumor (GIST)
  4. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG003
    title
    Low Grade (WHO G1/G2) Glioma (LGG)
  5. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG004
    title
    High Grade (WHO G3/G4) Glioma (HGG)
  6. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG005
    title
    Adenocarcinoma of the Small Intestine (ASI)
  7. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG006
    title
    Hairy Cell Leukemia (HCL)
  8. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG007
    title
    Multiple Myeloma (MM)
param Type
NUMBER
population Description
All-treated Subjects (ATS) population - Primary and expansion cohort combined
reporting Status
POSTED
time Frame
On-treatment deaths: Up to 85 months. Post-treatment survival follow-up deaths: Up to 92 months.
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice