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 FF10832 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-MD

USC
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)
FF10832 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 FF10832 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
12/31/2022
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • Evaluate how FF10832 works to treat patients with biliary tract cancers
  • Evaluate side effects of FF10832 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