Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors, Gastric Cancer, Transitional Cell Carcinoma of the Bladder

In brief

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Key facts

Study ID

NCT02318329

Run by

Five Prime Therapeutics, Inc.

People needed

79

Starts

2014-11-01

Expected to finish

2019-06-30

Last updated by the study team

2024-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Life expectancy of at least 3 months
• ECOG performance status of 0 to 1
• In sexually-active patients, willingness to use 2 effective methods of contraception
• Adequate hematological and organ function, confirmed by lab values
• Tumor tissue must be available for prospective determination of FGFR2b overexpression
• Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
• Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
• Measurable disease as defined by RECIST version 1.1

You may not qualify if…

• Untreated or symptomatic central nervous system (CNS) metastases
• Impaired cardiac function or clinically significant cardiac disease
• Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
• Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
• Retinal disease or a history of retinal disease or detachment
• Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea
• Major surgical procedures are not allowed ≤28 days prior to FPA144 administration
• Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study
• Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
• Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate
• History of prior malignancy except:
• a) Curatively treated non-melanoma skin cancer or
• b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
• c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
• Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay — San Francisco, California, United States
• Innovative Cancer Research Institute — Whittier, California, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Weill Cornell Medical Center — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute, LLC — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States
• Chonbuk National University Hospital — Jeonju, Jeollabuk-do, South Korea
• Seoul National University Bundang Hospital — Seongnam-si, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital, Yonsei University — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Gangnam Severance Hospital — Seoul, South Korea
• Korea University Anam Hospital — Seoul, South Korea
• Seoul St. Mary's Hospital — Seoul, South Korea
• SMG-SNU Boramae Medical Center — Seoul, South Korea
• China Medical University Hospital — Taichung, Taiwan
• National Cheng Kung University Hospital — Tainan, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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