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

Korábbi kezelés

• Planned radiotherapy during or after the study chemotherapy prior to disease progression.
• Receipt of chemotherapy or radiation within 28 days of study treatment
• 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.
• Use of another investigational product or device within 4 weeks of study entry or during study participation.

Más betegség

• Active infection that would preclude receipt of chemotherapy
• Moderate or severe cardiovascular disease per protocol
• Second primary malignancy for which treatment during the study period would be recommended if this cancer were not also present.
• Prior malignancy requiring treatment within the last 3 years

Egyéb

• Active pregnancy or lactation

• 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.
• Written informed consent/assent prior to any study-specific procedures
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Tissue available for translational study (paraffin block or new biopsy) .
• Adequate bone marrow, renal, and hepatic function as defined per protocol.
• No disease-modifying therapy, including investigational treatments, within 28 days prior to initiation of study treatment.
• Ability to swallow tablets
• 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.
• Patient must have measurable disease before the treatment