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



Status:Active, not recruiting
Conditions:Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:November 2014
End Date:May 2019

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A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors

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.

Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid
tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further
assess safety and evaluate PK of FPA144 in gastric cancer patients.

Part 2 patients will be enrolled and treated in order to further characterize safety and
preliminary efficacy in a selected cancer patient population with the greatest potential for
clinical benefit from FPA144 treatment.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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 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
We found this trial at
14
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Peter O'Dwyer, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
Principal Investigator: Joseph Chao, MD
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Jordan Berlin, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Peter Enzinger, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Daniel Catenacci, MD
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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Detroit, Michigan 48201
Principal Investigator: Amy M Weise, DO
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Detroit, MI
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Jaffer A Ajani, MD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Jeonju-si, 56171
Principal Investigator: Eun Kee Song, MD
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Jeonju-si,
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Los Angeles, California 90095
Principal Investigator: Zev A Wainberg, MD
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Los Angeles, CA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Johanna Bendell, MD
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New York, New York 10065
Principal Investigator: Manish A Shah, MD
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New York, NY
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San Antonio, Texas 78229
Principal Investigator: Drew Rasco, MD
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San Antonio, TX
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San Francisco, California 74158
Principal Investigator: Wolfgang M Korn, MD
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San Francisco, CA
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Whittier, California 90603
Principal Investigator: Stephen Huang, MD
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Whittier, CA
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