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

NCT03206177 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-08-07

Study results available
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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.

Conditions

  • Carcinosarcoma, Ovarian

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Kathleen Moore, MD · Obstetrics and Gynecology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2021-07-28
Completion
2024-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03206177 on ClinicalTrials.gov