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← Carcinosarcoma

NCT03206177 · STUDY IN CONTEXT

Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary

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

Completion of 4 cycles of CT + GB- completion of a cycle will be defined as receiving both carboplatin/paclitaxel and taking ≥75% of the doses of GB for the cycle.

Evaluable patients will be defined as patients who receive at least four cycles of study treatment.

→

secondary · POSTED

Progression free survival is defined as time from when the patient is registered on the study until RECIST v1.1 documented disease progression as per the protocol or death.

Patients who received at least four cycles of study drug.

→

secondary · POSTED

Overall survival defined as time from study entry to death

Patients who received at least four cycles of study drug

→

secondary · POSTED

Proportion of patients who had RECIST documented partial or complete response. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 10 mm when measured by CT and MRI; or ≥ 20 mm when measured by conventional techniques, including plain x-ray. Response was documented per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.

Patients who received four cycles of study drugs

→

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-carcinosarcoma
nct id
NCT03206177
trial label
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
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
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03206177
    outcome key
    om-0000
    source section id
    NCT03206177-om-0000
    source outcome index
    0
    endpoint
    Proportion of Patients With Completion of 4 Cycles of CT + GB
    endpoint definition
    Completion of 4 cycles of CT + GB- completion of a cycle will be defined as receiving both carboplatin/paclitaxel and taking ≥75% of the doses of GB for the cycle.
    time origin
    2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable patients will be defined as patients who receive at least four cycles of study treatment.
    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-carcinosarcoma
    nct id
    NCT03206177
    outcome key
    om-0001
    source section id
    NCT03206177-om-0001
    source outcome index
    1
    endpoint
    Median Progression Free Survival (Months)
    endpoint definition
    Progression free survival is defined as time from when the patient is registered on the study until RECIST v1.1 documented disease progression as per the protocol or death.
    time origin
    through study completion, an average of 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who received at least four cycles of study drug.
    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-carcinosarcoma
    nct id
    NCT03206177
    outcome key
    om-0002
    source section id
    NCT03206177-om-0002
    source outcome index
    2
    endpoint
    Median Overall Survival (Months)
    endpoint definition
    Overall survival defined as time from study entry to death
    time origin
    through study completion, an average of 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who received at least four cycles of study drug
    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-carcinosarcoma
    nct id
    NCT03206177
    outcome key
    om-0003
    source section id
    NCT03206177-om-0003
    source outcome index
    3
    endpoint
    Objective Response
    endpoint definition
    Proportion of patients who had RECIST documented partial or complete response. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 10 mm when measured by CT and MRI; or ≥ 20 mm when measured by conventional techniques, including plain x-ray. Response was documented per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.
    time origin
    within three years of study entry
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who received four cycles of study drugs
    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-carcinosarcoma
    nct id
    NCT03206177
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Paclitaxel/Carboplatin + Galunisertib
    regimen
    Galunisertib: Galunisertib 150mg po BID day 4-17 Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03206177-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03206177
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Paclitaxel/Carboplatin + Galunisertib
    regimen
    Galunisertib: Galunisertib 150mg po BID day 4-17 Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03206177-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03206177
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Paclitaxel/Carboplatin + Galunisertib
    regimen
    Galunisertib: Galunisertib 150mg po BID day 4-17 Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03206177-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03206177
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Paclitaxel/Carboplatin + Galunisertib
    regimen
    Galunisertib: Galunisertib 150mg po BID day 4-17 Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03206177-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03206177
    harm key
    EG000
    source section id
    NCT03206177-ae
    event group key
    EG000
    event group label
    Paclitaxel/Carboplatin + Galunisertib
    serious affected
    11
    serious at risk
    24
    other affected
    23
    other at risk
    24
    frequency threshold
    5
    collection period
    Within 4 years of study entry
    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