A Phase II Evaluation of Afatinib
Conditions
Corpus Uteri | Other Female Genital
Phase II
Volunteers
Health Professionals
What is the purpose of this trial?
Primary objective
- To assess the activity of afatinib in patients with persistent or recurrent USC overexpressing HER2/neu with the frequency of patients who survive progression-free for at least 6 months after initiating therapy. b.
Secondary objectives
- To assess objective response rate (ORR) and durable disease control rate (DDCR),
- To assess overall survival (OS)
- To assess the safety profile of afatinib in USC patients
Exploratory/correlative objectives
- To systematically evaluate HER2/neu expression/amplification using standardized scoring criteria for both breast and gastric cancer and correlate clinical response in EC patients with HER2/neu scoring results.
- To correlate ORR, PFS, and OS with the presence/absence of PIK3CA (phosphatidyl inositol 3-kinase catalytic subunit) and FBXW7 (F-box/WD repeat-containing protein) mutations by standard Sanger sequencing, and presence/absence of Cyclin E2 overexpression by IHC in endometrial cancer patients overexpressing HER2/neu treated with Afatinib
To study:
- HER2/neu extracellular domain (ECD) circulating levels in the plasma of USC patients overexpressing HER2/neu before, and during Afatinib treatment to elucidate whether changes in HER2/neu ECD would predict response to Afatinib and
- To determine peripheral blood natural killer (NK) cell numbers and activity in HER2/neu+ USC patients before, and during Afatinib treatment to assess the possible therapeutic contributions of immune mechanisms of action of Afatinib.
- Ages18 years and younger
- GenderFemale only
- Trial withYale Cancer Center
- Start Date05/24/2018
- End Date06/30/2023
I'm interested in volunteering
If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343
Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alessia Donadio, MD
- Amy Rodrigues
- Anamika Katoch, MD
- Andrea Brennan
- Andrea Martelli
- Andrea Silber, MD
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Daniel P. Petrylak, MD
- David Witt, MD
- Elan Gorshein, DO, JD, MPH
- Elena Ratner, MD
- Gary Altwerger, MD
- Gulden Menderes, MD
- Harold Tara Jr, MD
- James Vredenburgh, MD
- Jane Kanowitz, MD
- Jason Haldas, MD
- Jaykumar Thumar, MBBS, MD
- Jeremy Kortmansky, MD
- Johanna LaSala, MD
- Justin Harold, MD
- Justin Persico, MD
- Karishma Mehra, MBBS
- Katherine Harvey, MD, MPH
- Kelsey Martin, MD
- Kert Sabbath, MD, FACP
- Khanh Nguyen, MD
- Kristen Hoxie
- M. Sung Lee, MD
- Madeline Santiago
- Masoud Azodi, MD
- Michael Cohenuram, MD
- Neal Fischbach, MD
- Pawan Karanam, MD
- Pei Hui, PhD, MD
- Peter Schwartz, MD
- Robert Legare, MD
- Sara Anastasio, RN
- Sarah Carlson
- Stephanie Cerrito
- Stephen Lattanzi, MD
- Su Hsien Lim, MD
- Susan Rabinowe, MD
- Vaagn Andikyan, MD
- Victor Chang, MD
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Zia Rahman, MD
- Last Updated07/15/2021
- Study HIC#1503015437