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

• Status: Active, not recruiting
• Trial end date: 2023-08-19
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. 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.

2. Written informed consent/assent prior to any study-specific procedures

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

4. Tissue available for translational study (paraffin block or new biopsy) .

5. Adequate bone marrow, renal, and hepatic function as defined per protocol.

6. No disease-modifying therapy, including investigational treatments, within 28 days prior to initiation of study treatment.

7. Ability to swallow tablets

8. 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.

9. Patient must have measurable disease before the treatment

Exclusion Criteria:

1. Planned radiotherapy during or after the study chemotherapy prior to disease progression.

2. Receipt of chemotherapy or radiation within 28 days of study treatment

3. 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.

4. Active infection that would preclude receipt of chemotherapy

5. Moderate or severe cardiovascular disease per protocol

6. Active pregnancy or lactation

7. Second primary malignancy for which treatment during the study period would be recommended if this cancer were not also present.

8. Prior malignancy requiring treatment within the last 3 years

9. Use of another investigational product or device within 4 weeks of study entry or during study participation.