NCT03206177

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

Feasibility IB Trial of Paclitaxel/Carboplatin + Galunisertib (a Small Molecule Inhibitor of the Kinase Domain of Type 1 TGF-B Receptor) in Patients With Newly Diagnosed, Persistent or Recurrent Carcinosarcoma of the Uterus or Ovary

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Carcinosarcoma, Ovarian

Interventions

Type	Name	Description
DRUG	Galunisertib	Galunisertib 150mg po BID day 4-17
DRUG	Paclitaxel	IV Day 1: Paclitaxel 175 mg/m2 over 3 hours
DRUG	Carboplatin	IV Day 1: Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)

Timeline

• Start date: 2017-08-23
• Primary completion: 2021-07-28
• Completion: 2024-02-13
• First posted: 2017-07-02
• Last updated: 2024-08-07
• Results posted: 2024-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study