Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary (NCT03206177) | Clinical Trial Compass
CompletedPhase 1
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
United States26 participantsStarted 2017-08-23
Plain-language summary
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.
Who can participate
Age range18 Years – 99 Years
SexFEMALE
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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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Proportion of Patients With Completion of 4 Cycles of CT + GB