Bladder Cancer Clinical Trial

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

Summary

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.

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Full Description

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.

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Eligibility Criteria

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
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

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

79

Study ID:

NCT02318329

Recruitment Status:

Completed

Sponsor:

Five Prime Therapeutics, Inc.

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There are 25 Locations for this study

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City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay
San Francisco California, 74158, United States
Innovative Cancer Research Institute
Whittier California, 90603, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Weill Cornell Medical Center
New York New York, 10065, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Sarah Cannon Research Institute, LLC
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
The University of Texas M.D. Anderson Cancer Center
Houston Texas, 77030, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio Texas, 78229, United States
Chonbuk National University Hospital
Jeonju Jeollabuk-do, 561-7, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 463-7, Korea, Republic of
Seoul National University Hospital
Seoul , 110-7, Korea, Republic of
Severance Hospital, Yonsei University
Seoul , 120-7, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Gangnam Severance Hospital
Seoul , 135-7, Korea, Republic of
Korea University Anam Hospital
Seoul , 136-7, Korea, Republic of
Seoul St. Mary's Hospital
Seoul , 137-7, Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul , 156-7, Korea, Republic of
China Medical University Hospital
Taichung , 40447, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

79

Study ID:

NCT02318329

Recruitment Status:

Completed

Sponsor:


Five Prime Therapeutics, Inc.

How clear is this clinincal trial information?

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