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.
60 studies on the registry are indexed under Carcinosarcoma; 12 are open to participants now.
This study's enrollment of 26 is below the median of 48 across 52 interventional studies indexed under Carcinosarcoma.
Browse Carcinosarcoma studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2017 to primary completion in Jul 2021, 47 months.
Results were first posted in Aug 2024, 3 years after primary completion.
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Studies of the drugs tested here: LY-2157299 · Paclitaxel · Carboplatin