Trial · NCT03206177
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
NCT03206177, Phase 1, Completed, University of Oklahoma; results first posted 2024-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary. Trials, record NCT03206177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03206177
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
- NCT number
- NCT03206177
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- University of Oklahoma
- Conditions
- Carcinosarcoma, Ovarian
- Interventions
- Galunisertib, Paclitaxel, Carboplatin
- First posted
- 2017-07-02
- Last updated
- 2024-08-07
- Results first posted
- 2024-08-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Completion of 4 Cycles of CT + GB | 2 years | 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. |
| Secondary | Median Progression Free Survival (Months) | through study completion, an average of 3 years | 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. |
| Secondary | Median Overall Survival (Months) | through study completion, an average of 3 years | Overall survival defined as time from study entry to death |
| Secondary | Objective Response | within three years of study entry | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Completion of 4 Cycles of CT + GB | 2 years | Evaluable patients will be defined as patients who receive at least four cycles of study treatment. | proportion of patients | NUMBER |
| SECONDARY | Median Progression Free Survival (Months) | through study completion, an average of 3 years | Patients who received at least four cycles of study drug. | months | MEDIAN |
| SECONDARY | Median Overall Survival (Months) | through study completion, an average of 3 years | Patients who received at least four cycles of study drug | months | MEDIAN |
| SECONDARY | Objective Response | within three years of study entry | Patients who received four cycles of study drugs | proportion of patients with CR/PR | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Completion of 4 Cycles of CT + GB | Paclitaxel/Carboplatin + Galunisertib | 0.7826 | 90% Confidence Interval 0.5961 to 0.9102 | proportion of patients | |
| Median Progression Free Survival (Months) | Paclitaxel/Carboplatin + Galunisertib | 6.55 | 95% Confidence Interval 5.42 to 10.81 | months | |
| Median Overall Survival (Months) | Paclitaxel/Carboplatin + Galunisertib | 18.91 | 95% Confidence Interval 10.81 to NA | months | |
| Objective Response | Paclitaxel/Carboplatin + Galunisertib | 0.33 | 95% Confidence Interval 0.15 to 0.57 | proportion of patients with CR/PR |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paclitaxel/Carboplatin + Galunisertib | 24 | |
| Overall Study | COMPLETED | Paclitaxel/Carboplatin + Galunisertib | 23 | |
| Overall Study | NOT COMPLETED | Paclitaxel/Carboplatin + Galunisertib | 1 |
Source ClinicalTrials.gov
Adverse events47
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANEMIA | Blood and lymphatic system disorders | Paclitaxel/Carboplatin + Galunisertib | 4 | 24 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Paclitaxel/Carboplatin + Galunisertib | 10 | 24 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Paclitaxel/Carboplatin + Galunisertib | 4 | 24 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Paclitaxel/Carboplatin + Galunisertib | 2 | 24 | |
| other | CONSTIPATION | Gastrointestinal disorders | Paclitaxel/Carboplatin + Galunisertib | 4 | 24 | |
| other | GERD | Gastrointestinal disorders | Paclitaxel/Carboplatin + Galunisertib | 2 | 24 | |
| other | INTERMITTENT NAUSEA | Gastrointestinal disorders | Paclitaxel/Carboplatin + Galunisertib | 3 | 24 | |
| other | NAUSEA | Gastrointestinal disorders | Paclitaxel/Carboplatin + Galunisertib | 9 | 24 | |
| other | VOMITING | Gastrointestinal disorders | Paclitaxel/Carboplatin + Galunisertib | 2 | 24 | |
| other | FATIGUE | General disorders | Paclitaxel/Carboplatin + Galunisertib | 11 | 24 |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paclitaxel/Carboplatin + Galunisertib | 1 | 24 |
| Total, other adverse events | Paclitaxel/Carboplatin + Galunisertib | 23 | 24 |
| Total, serious adverse events | Paclitaxel/Carboplatin + Galunisertib | 11 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03206177
GET https://conductscience.org/api/trials/v1/NCT03206177/events?page=2