A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors

Study Name
	A Phase 1 Dose-escalation Study of FF–10832 for the Treatment of Advanced Solid Tumors
ClinicalTrials.gov Identifier (if applicable)
	NCT03440450
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Chemotherapy Other Novel Therapy
Study Center
Institution Name
	Honor Health
Institution Address
	10460 N. 92nd St Ste. 200 and 400
City
	Scottsdale
State
	Arizona
Zip Code
	85258
Country
	United States
Phone
	(480) 323-1364
Website
	https://www.honorhealth.com/locations/specialty-care/virginia-g-piper-cancer-center
List additional Institutions (include address, phone number, and website)
	Sarah Cannon Research Institute in Colorado 1800 Williams Street Suite 300 Denver, CO 80218 Site contact phone number for patients: 720-754-2610 https://sarahcannon.com/locations/denver/Sarah Cannon Research Institute in Tennessee Tennessee Oncology 250 25th Ave North Ste 100 Nashville, TN 37203 Referral line: 615-840-3789 extension 44286 https://sarahcannon.com/physicians/profile/Dr-Erika-P-Hamilton-MDUSC Hoag Memorial Hospital Presbyterian/ USC Norris Comprehensive Cancer Center 1441 Eastlake Ave. Los Angeles, CA 90033 Xiomara Menendez (Senior Program Manager) Xiomara.Menendez@med.usc.edu Lorraine Martinez (Nurse Protocol Coordinator) Lorraine.Martinez@med.usc.edu
Study Contacts
Principal Investigator
	Erkut Borazanci
P.I. Phone
	(480) 323-1350
P.I. Email
	clinicaltrials@honorhealth.com
List additional Principal Investigators (include phone number and email)
	Gerald Falchook, MD Erika Hamilton, MD Jacob Thomas, MD
Study Coordinator
	Nurse Navigation Team
Study Coordinator Phone
	(833) 354-6667
Study Coordinator Email
	clinicaltrials@honorhealth.com
List additional Study Coordinators (include phone number and email)
	Sarah Cannon Research Institute in Colorado: Referral line: 720-754-2610; email not available Sarah Cannon Research Institute in Tennessee: Referral line: 615-840-3789 extension 44286; email not available USC Xiomara Menendez (Senior Program Manager) Xiomara.Menendez@med.usc.edu Lorraine Martinez (Nurse Protocol Coordinator) Lorraine.Martinez@med.usc.edu
OVERVIEW – in layman’s terms (150 words max)
	FF–10832 encapsulates gemcitabine in a liposome, which is believed to improve the delivery of the medicine to the tumor. The current part of this study is evaluating FF–10832 in patients with biliary tract cancer (cholangiocarcinoma or gallbladder cancer) that has either spread to other parts of the body or can’t be removed completely with surgery.
Enrollment
	15 patients
Study Start Date
	01/01/2022
Estimated Completion Date
	3/31/2025
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	Evaluate how FF–10832 works to treat patients with biliary tract cancers Evaluate side effects of FF–10832 in patients with biliary tract cancers.
Inclusion Criteria – Patients Must:
	Be at least 18 years old Provide consent by signing the informed consent form Have cholangiocarcinoma or gallbladder carcinoma that has spread or is not able to be treated surgically, and has not had more than 3 prior therapies for the tumor. Details about prior therapies will be evaluated by the investigator to determine eligibility Acceptable performance status as determined by the ECOG score (0 or 1) Have a life expectancy of at least 3 months Acceptable laboratory parameters Acceptable kidney function Acceptable EKG Negative serum pregnancy test if woman of childbearing potential, or unable to have children due to hysterectomy or postmenopausal for at least 24 months. Methods to avoid pregnancy must be agreed to.
Exclusion Criteria – Patients Must NOT:
	Have had an allergy to gemcitabine Have serious cardiac conditions within the past 6 months Have active central nervous system malignant disease Have known positive HIV, hepatitis B surface antigen, or hepatitis C virus Be pregnant or breast-feeding
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	Physical exam and collection of health and medication history Vital signs, 12-lead EKG Blood collection for various lab tests Urine collection for urinalysis Scans for determining extent of disease (example: CT, MRI) Biopsy of tumor, or if tumor cannot be biopsied, collect tissue that was collected in the past (archival)
POTENTIAL SIDE-EFFECTS – in layman’s terms
	Nausea Fever Fatigue Decreased appetites Low red blood cell count Rash Vomiting