CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Galunisertib +2 moredrug
Likely dose
Galunisertib 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03206177
NCT03206177Phase 1Completed
CompareCT.gov

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

University of Oklahoma·interventional·Posted Jul 2, 2017·Updated Aug 7, 2024

In Brief

A Phase 1 clinical trial evaluating Galunisertib, Paclitaxel, and 1 other intervention for Carcinosarcoma, Ovarian. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinosarcoma, Ovarian
CountriesUnited States
CollaboratorsEli Lilly and Company

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartAug 23, 2017
Primary CompletionJul 28, 2021
Study CompletionFeb 13, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9 years ago

Interventions

Galunisertibdrug

Galunisertib 150mg po BID day 4-17

Paclitaxeldrug

IV Day 1: Paclitaxel 175 mg/m2 over 3 hours

Carboplatindrug

IV Day 1: Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)