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← Osteosarcoma

NCT02048371 · STUDY IN CONTEXT

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort A (liposarcoma) and Cohort B (osteosarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, where a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Source null

→

primary · POSTED

The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort C (Ewing/Ewing-like sarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1.

Source null

→

secondary · POSTED

Common Toxicity Criteria, also referred to as the Common Terminology Criteria for Adverse Events (CTCAE), is a standardized classification of side effects used in assessing drugs for cancer therapy. Cohorts A, B, C, and D.

Source null

→

secondary · POSTED

The overall response rate (ORR) is the percentage of patients whose cancer shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1

Source null

→

secondary · POSTED

The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Participants who started on placebo in Cohorts A and B, then crossed over to active drug after progression.

→

secondary · POSTED

The response rate (RR) is the percentage of patients whose cancer shrinks or disappears after treatment.

Participants who started on placebo then crossed over to active drug.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT02048371
trial label
SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
8
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0000
    source section id
    NCT02048371-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS). Cohort A and Cohort B
    endpoint definition
    The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort A (liposarcoma) and Cohort B (osteosarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, where a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    time origin
    up to 3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0001
    source section id
    NCT02048371-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E
    endpoint definition
    The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort C (Ewing/Ewing-like sarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1.
    time origin
    up to 16 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0002
    source section id
    NCT02048371-om-0002
    source outcome index
    2
    endpoint
    The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts.
    endpoint definition
    Common Toxicity Criteria, also referred to as the Common Terminology Criteria for Adverse Events (CTCAE), is a standardized classification of side effects used in assessing drugs for cancer therapy. Cohorts A, B, C, and D.
    time origin
    up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0003
    source section id
    NCT02048371-om-0003
    source outcome index
    3
    endpoint
    Overall Response Rate (ORR). All Cohorts.
    endpoint definition
    The overall response rate (ORR) is the percentage of patients whose cancer shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1
    time origin
    up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0004
    source section id
    NCT02048371-om-0004
    source outcome index
    4
    endpoint
    Progression-free Survival (PFS), Cohorts A and B, After Crossover.
    endpoint definition
    The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
    time origin
    up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who started on placebo in Cohorts A and B, then crossed over to active drug after progression.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0005
    source section id
    NCT02048371-om-0005
    source outcome index
    5
    endpoint
    Response Rate (RR), Cohorts A and B, After Crossover.
    endpoint definition
    The response rate (RR) is the percentage of patients whose cancer shrinks or disappears after treatment.
    time origin
    up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who started on placebo then crossed over to active drug.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort A: Liposarcoma
    regimen
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort A: Liposarcoma, Placebo
    regimen
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Cohort B: Osteosarcoma
    regimen
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Cohort B: Osteosarcoma, Placebo
    regimen
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort C: Ewing Sarcoma
    regimen
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cohort D: Rhabdomyosarcoma
    regimen
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0001#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Cohort E: Mesenchymal Chondrosarcoma
    regimen
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0001#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cohort A: Liposarcoma
    regimen
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0002#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Cohort A: Liposarcoma, Placebo
    regimen
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0002#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Cohort B: Osteosarcoma
    regimen
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0002#groups/OG002
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Cohort B: Osteosarcoma, Placebo
    regimen
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0002#groups/OG003
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    outcome key
    om-0002
    arm key
    OG004
    arm label
    Cohort C: Ewing Sarcoma
    regimen
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02048371-om-0002#groups/OG004
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    harm key
    EG000
    source section id
    NCT02048371-ae
    event group key
    EG000
    event group label
    Cohort A: Liposarcoma
    serious affected
    28
    serious at risk
    39
    other affected
    26
    other at risk
    39
    frequency threshold
    5
    collection period
    Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
    event definition
    Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    harm key
    EG001
    source section id
    NCT02048371-ae
    event group key
    EG001
    event group label
    Cohort A: Liposarcoma, Placebo
    serious affected
    7
    serious at risk
    9
    other affected
    8
    other at risk
    9
    frequency threshold
    5
    collection period
    Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
    event definition
    Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    harm key
    EG002
    source section id
    NCT02048371-ae
    event group key
    EG002
    event group label
    Cohort B: Osteosarcoma
    serious affected
    24
    serious at risk
    33
    other affected
    26
    other at risk
    33
    frequency threshold
    5
    collection period
    Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
    event definition
    Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    harm key
    EG003
    source section id
    NCT02048371-ae
    event group key
    EG003
    event group label
    Cohort B: Osteosarcoma, Placebo
    serious affected
    7
    serious at risk
    9
    other affected
    6
    other at risk
    9
    frequency threshold
    5
    collection period
    Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
    event definition
    Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    harm key
    EG004
    source section id
    NCT02048371-ae
    event group key
    EG004
    event group label
    Cohort C: Ewing Sarcoma
    serious affected
    21
    serious at risk
    30
    other affected
    22
    other at risk
    30
    frequency threshold
    5
    collection period
    Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
    event definition
    Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    harm key
    EG005
    source section id
    NCT02048371-ae
    event group key
    EG005
    event group label
    Cohort D: Rhabdomyosarcoma
    serious affected
    4
    serious at risk
    6
    other affected
    2
    other at risk
    6
    frequency threshold
    5
    collection period
    Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
    event definition
    Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    harm key
    EG006
    source section id
    NCT02048371-ae
    event group key
    EG006
    event group label
    Cohort D: Pediatric
    serious affected
    2
    serious at risk
    4
    other affected
    1
    other at risk
    4
    frequency threshold
    5
    collection period
    Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
    event definition
    Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT02048371
    harm key
    EG007
    source section id
    NCT02048371-ae
    event group key
    EG007
    event group label
    Cohort E: Mesenchymal Chondrosarcoma
    serious affected
    0
    serious at risk
    1
    other affected
    0
    other at risk
    1
    frequency threshold
    5
    collection period
    Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
    event definition
    Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice