A Phase 1 interventional study of Galunisertib and Paclitaxel in Carcinosarcoma, Ovarian, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by University of Oklahoma · Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
Drug: Galunisertib · Drug: Paclitaxel · Drug: Carboplatin
Galunisertib 150mg po BID day 4-17
IV Day 1: Paclitaxel 175 mg/m2 over 3 hours
IV Day 1: Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
Proportion of Patients With Completion of 4 Cycles of CT + GB
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 frame: 2 years
Median Progression Free Survival (Months)
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 frame: through study completion, an average of 3 years
Median Overall Survival (Months)
Overall survival defined as time from study entry to death
Time frame: through study completion, an average of 3 years
Objective Response
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 frame: within three years of study entry
This single site study conducted at the University of Oklahoma Stephenson Cancer Center enrolled 26 participants between August 2017 and March 2021. The first participant was enrolled on August 23, 2017 and the last participant was enrolled on March 29, 2021.
| Milestone | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| Started | 24 |
| Completed | 23 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| proportion of patients | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| Proportion of Patients With Completion of 4 Cycles of CT + GB | 0.7826 (0.5961 to 0.9102) |
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.
| months | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| Median Progression Free Survival (Months) | 6.55 (5.42 to 10.81) |
Overall survival defined as time from study entry to death
| months | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| Median Overall Survival (Months) | 18.91 (10.81 to NA) |
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.
| proportion of patients with CR/PR | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| Objective Response | 0.33 (0.15 to 0.57) |
Collected over Within 4 years of study entry. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paclitaxel/Carboplatin + Galunisertib | 1/24 (4.2%) | 11/24 (45.8%) | 23/24 (95.8%) |
| Event | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| ARTRIAL FIBRILLATIONCardiac disorders | 1/24 |
| SMALL BOWEL OBSTRUCTIONGastrointestinal disorders | 1/24 |
| VOMITINGGastrointestinal disorders | 1/24 |
| DEATHGeneral disorders | 1/24 |
| FEVERGeneral disorders | 1/24 |
| NEUTROPENIC FEVERGeneral disorders | 1/24 |
| PULMONARY INFECTIONInfections and infestations | 1/24 |
| URINARY TRACT INFECTIONInfections and infestations | 1/24 |
| DRUG INDUCED LIVER INJURYInjury, poisoning and procedural complications | 1/24 |
| LEFT LEG FRACTUREMusculoskeletal and connective tissue disorders | 1/24 |
| Event | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| NEUROPATHYNervous system disorders | 13/24 |
| FATIGUEGeneral disorders | 11/24 |
| NEUTROPENIABlood and lymphatic system disorders | 10/24 |
| NAUSEAGastrointestinal disorders | 9/24 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 8/24 |
| URINARY TRACT INFECTIONInfections and infestations | 6/24 |
| RASHSkin and subcutaneous tissue disorders | 5/24 |
| ANEMIABlood and lymphatic system disorders | 4/24 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 4/24 |
| CONSTIPATIONGastrointestinal disorders | 4/24 |
Patients who enrolled in study
| Age, Continuous(years) | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| Mean | 68.96 ± 10.16 |
| Sex: Female, Male(Participants) | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| Female | 24 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 23 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| United States | 24 |
| BMI(kg/m^2) | Paclitaxel/Carboplatin + Galunisertib |
|---|---|
| Mean | 27.08 ± 8.40 |
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University of Oklahoma