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

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.

Inclusion Criteria:

- 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. Eastern Cooperative Oncology
Group (ECOG) performance status 0-2. Tissue available for translational study
(paraffin block or new biopsy). 5. Adequate bone marrow, renal, and hepatic function
per study requirements. Women of childbearing potential must be willing to use a
highly effective form of birth control during the study and for 6 months after the
last dose of galunsertib.

Exclusion Criteria:

- Planned radiotherapy during or after the study chemotherapy prior to disease
progression. Chemotherapy or radiation within 28 days of study treatment. Major
surgical procedure or a significant traumatic injury within 28 days prior to study
treatment. Active infection that would preclude receipt of chemotherapy. Moderate or
severe cardiovascular disease. Active pregnancy or lactation. 7. Second primary
malignancy for which treatment during the study period would be recommended. 8. Prior
malignancy requiring treatment within the last 3 years. Use of another investigational
product or device within 4 weeks of study entry or during study participation.