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← Chondrosarcoma

NCT01154452 · STUDY IN CONTEXT

Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma

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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)

Source null

→

primary · POSTED

Progression-free survival (PFS) of the combination of RO4929097 with and without GDC-0449 in patients with advanced sarcoma. (Phase II)

Source null

→

secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions

Source null

→

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-chondrosarcoma
nct id
NCT01154452
trial label
Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
3
harms Count
4
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0000
    source section id
    NCT01154452-om-0000
    source outcome index
    0
    endpoint
    Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)
    endpoint definition
    Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)
    time origin
    Up to 28 days
    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-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0001
    source section id
    NCT01154452-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    Progression-free survival (PFS) of the combination of RO4929097 with and without GDC-0449 in patients with advanced sarcoma. (Phase II)
    time origin
    6 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-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0002
    source section id
    NCT01154452-om-0002
    source outcome index
    2
    endpoint
    Response Rate (CR + PR) as Assessed by RECIST 1.1 (Phase Ib and II)
    endpoint definition
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
    time origin
    Up to 4 months
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0000
    arm key
    OG000
    arm label
    All Phase Ib Participants
    regimen
    All Phase Ib Participants
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01154452-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (Gamma-secretase Inhibitor RO4929097)
    regimen
    Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-21. Gamma-Secretase Inhibitor RO4929097: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01154452-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (Vismodegib and Gamma-secretase Inhibitor RO4929097)
    regimen
    Patients receive vismodegib PO and gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-21. Gamma-Secretase Inhibitor RO4929097: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Vismodegib: Given PO
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01154452-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0002
    arm key
    OG000
    arm label
    RO4929097 10mg
    regimen
    RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01154452-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0002
    arm key
    OG001
    arm label
    RO4929097 15 mg
    regimen
    RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01154452-om-0002#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0002
    arm key
    OG002
    arm label
    ARM 1 - RO4929097: 15 mg PO QD
    regimen
    ARM 1 - RO4929097: 15 mg PO QD
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01154452-om-0002#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-chondrosarcoma
    nct id
    NCT01154452
    outcome key
    om-0002
    arm key
    OG003
    arm label
    ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
    regimen
    ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01154452-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chondrosarcoma
    nct id
    NCT01154452
    harm key
    EG000
    source section id
    NCT01154452-ae
    event group key
    EG000
    event group label
    RO4929097 10mg
    serious affected
    2
    serious at risk
    6
    other affected
    4
    other at risk
    6
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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-chondrosarcoma
    nct id
    NCT01154452
    harm key
    EG001
    source section id
    NCT01154452-ae
    event group key
    EG001
    event group label
    RO4929097 15 mg
    serious affected
    2
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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-chondrosarcoma
    nct id
    NCT01154452
    harm key
    EG002
    source section id
    NCT01154452-ae
    event group key
    EG002
    event group label
    ARM 1 - RO4929097: 15 mg PO QD
    serious affected
    11
    serious at risk
    35
    other affected
    26
    other at risk
    35
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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-chondrosarcoma
    nct id
    NCT01154452
    harm key
    EG003
    source section id
    NCT01154452-ae
    event group key
    EG003
    event group label
    ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
    serious affected
    8
    serious at risk
    33
    other affected
    23
    other at risk
    33
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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