NCT03206177 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2024-08-07

This is a Phase 1 B feasibility trial with Galunsertib, a TGFβ inhibitor, in combination with carboplatin/paclitaxel in patients with newly diagnosed, persistent or recurrent carcinosarcoma of the uterus or ovary. The objective of the study is to determine whether this drug combination is safe for this patient population and to see if it is effective in shrinking cancers, keeping them from growing or helping patients live longer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Proportion of Patients With Completion of 4 Cycles of CT + GB

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outcome · POSTED

Median Progression Free Survival (Months)

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outcome · POSTED

Median Overall Survival (Months)

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outcome · POSTED

Objective Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Women ≥ 18 years old with a diagnosis of primary, recurrent or progressive uterine, ovarian, fallopian tube or peritoneal carcinosarcoma, for whom treatment with combination paclitaxel and carboplatin is recommended. 2. Written informed consent/assent prior to any study-specific procedures 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 4. Tissue available for translational study (paraffin block or new biopsy) . 5. Adequate bone marrow, renal, and hepatic function as defined per protocol. 6. No disease-modifying therapy, including investigational treatments, within 28 days prior to initiation of study treatment. 7. Ability to swallow tablets 8. For Women of child-bearing potential:Willingness to use a highly effective method of contraception during the study and for 6 months following the last dose of galunisertib. Negative beta human chorionic gonadotropin pregnancy test documented within 7 days prior to initiation of study drug. 9. Patient must have measurable disease before the treatment Exclusion Criteria: 1. Planned radiotherapy during or after the study chemotherapy prior to disease progression. 2. Receipt of chemotherapy or radiation within 28 days of study treatment 3. Have had a major surgical procedure or a significant traumatic injury within 28 days prior to study treatment; Minor procedures such as biopsy within 7 days prior to study treatment are allowed. 4. Active infection that would preclude receipt of chemotherapy 5. Moderate or severe cardiovascular disease per protocol 6. Active pregnancy or lactation 7. Second primary malignancy for which treatment during the study period would be recommended if this cancer were not also present. 8. Prior malignancy requiring treatment within the last 3 years 9. Use of another investigational product or device within 4 weeks of study entry or during study participation.
gender Based: true
gender Description: The patient population for this study only applies to females.
healthy Volunteers: false
maximum Age: 99 Years
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients will receive the following in every cycle (1 cycle=28days). * Paclitaxel - 175 mg/m2 over 3 hours via IV on Day 1 * Carboplatin - AUC 6\* (or AUC 5\*) over 1 hour via IV on Day 1 * Galunisertib - 150mg orally twice a day on Days 4-17
intervention Names
Drug: Galunisertib
Drug: Paclitaxel
Drug: Carboplatin
label
Paclitaxel/Carboplatin + Galunisertib
type
EXPERIMENTAL

interventions

arm Group Labels
Paclitaxel/Carboplatin + Galunisertib
description
Galunisertib 150mg po BID day 4-17
name
Galunisertib
type
DRUG
arm Group Labels
Paclitaxel/Carboplatin + Galunisertib
description
IV Day 1: Paclitaxel 175 mg/m2 over 3 hours
name
Paclitaxel
type
DRUG
arm Group Labels
Paclitaxel/Carboplatin + Galunisertib
description
IV Day 1: Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
name
Carboplatin
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 26
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Proportion of Patients With Completion of 4 Cycles of CT + GB
time Frame
2 years

secondary Outcomes

description
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.
measure
Median Progression Free Survival (Months)
time Frame
through study completion, an average of 3 years
description
Overall survival defined as time from study entry to death
measure
Median Overall Survival (Months)
time Frame
through study completion, an average of 3 years
description
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.
measure
Objective Response
time Frame
within three years of study entry

Full study description

brief Summary: This is a Phase 1 B feasibility trial with Galunsertib, a TGFβ inhibitor, in combination with carboplatin/paclitaxel in patients with newly diagnosed, persistent or recurrent carcinosarcoma of the uterus or ovary. The objective of the study is to determine whether this drug combination is safe for this patient population and to see if it is effective in shrinking cancers, keeping them from growing or helping patients live longer.
detailed Description: Patients who consent to this study will receive treatment for four 28 day cycles unless they are unable to continue study treatment due to toxicity or disease progression. Paclitaxel and carboplatin will be given intravenously on day 1 of each cycle and galunisertib in pill form on days 4-17. No medicine will be given on days 17-28 of each cycle. Patients may have the option of continuing treatment with the study drug if they complete the 4 cycles the study requires. Subjects will receive tests and procedures that are part of regular cancer care as well as those required for the purposes of the study. Blood samples will be taken to monitor the level of study drug in the blood. Patients will have the option of allowing blood and tumor samples to be used for future research.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
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source kind
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https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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payload
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id
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nct id
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occurrences
context exact
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end
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exact text
NCT03206177
start
0
offset unit
unicode_code_points
query cond
Uterine Sarcoma
query disease state id
ds-uterine-sarcoma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice