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TGF-beta Receptor Kinase Inhibitor

Galunisertib + Paclitaxel for Triple Negative Breast Cancer

Phase 1
Waitlist Available
Led By Vandana Abramson, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on-treatment date to date of disease progression, assessed up to 3 years
Awards & highlights

Study Summary

This trial is testing Galunisertib + Paclitaxel to treat patients with androgen receptor negative or triple negative breast cancer.

Eligible Conditions
  • Triple Negative Breast Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on-treatment date to date of disease progression, assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and on-treatment date to date of disease progression, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum Tolerated Dose (MTD) of paclitaxel + LY2157299
Secondary outcome measures
Overall Response Rate (ORR)
Progression-Free Survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Paclitaxel, Galunisertib)Experimental Treatment3 Interventions
Patients receive Paclitaxel IV on days 1, 8, and 15. Patients also receive GalunisertibPO BID on days 1-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Galunisertib
2016
Completed Phase 3
~370
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,904 Total Patients Enrolled
28 Trials studying Breast Cancer
6,594 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,246 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Vandana Abramson, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center
4 Previous Clinical Trials
185 Total Patients Enrolled

Media Library

Galunisertib (TGF-beta Receptor Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02672475 — Phase 1
Breast Cancer Research Study Groups: Treatment (Paclitaxel, Galunisertib)
Breast Cancer Clinical Trial 2023: Galunisertib Highlights & Side Effects. Trial Name: NCT02672475 — Phase 1
Galunisertib (TGF-beta Receptor Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02672475 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other examinations have been conducted to assess the efficacy of Galunisertib?

"Galunisertib is the focus of 836 active clinical trials, with 227 being in Phase 3. In terms of geographical availability, Woolloongabba, Queensland serves as a hub for many of these studies while 45717 sites around the world are conducting research on Galunisertib."

Answered by AI

What is the maximum capacity of participants in this medical experiment?

"Unfortunately, this clinical trial does not appear to be currently accepting patients. It was initially listed on the 3rd of March 2016 and last edited 12th of May 2022. Alternately, there are 4569 trials recruiting participants with her2/neu negative and 836 studies enlisting individuals for Galunisertib at this time."

Answered by AI

What therapeutic issues is Galunisertib most frequently prescribed to address?

"Galunisertib is capable of treating neoplasm metastasis, kaposi sarcoma, and advance directives."

Answered by AI

Are there any additional participants being sought for the experiment?

"This medical trial is no longer actively accepting participants. It was first posted on March 1st, 2016 and last updated on May 12th, 2022. For those still searching for clinical trials to join, there are currently 4569 studies recruiting patients with HER2/neu negative conditions, as well as 836 active studies looking for Galunisertib patients."

Answered by AI

What are the risk factors associated with Galunisertib treatment?

"Due to the limited data available, Galunisertib has been given a score of 1 in terms of its safety when evaluated by Power. It is currently undergoing Phase One clinical trials for further evaluation."

Answered by AI
~3 spots leftby Mar 2025