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BRIEF TITLE: Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors

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


  • Org Study ID: FPA144-001
  • Secondary ID:
  • NCT ID: NCT02318329
  • NCT Alias:
  • Sponsor: Five Prime Therapeutics, Inc. - Industry
  • Source: Five Prime Therapeutics, Inc.

Brief 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.

Detailed 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: November 2014 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of Grade 3 and Grade 4 adverse events (AEs) and clinical laboratory abnormalities defined as dose-limiting toxicities (Part 1 only).

Primary Outcome 1 - Time Frame: 4 weeks on average

Primary Outcome 2 - Measure: Incidence of AEs and clinical laboratory abnormalities (Parts 1B and 2 only)

Primary Outcome 2 - Time Frame: 16 weeks on average

Condition:

  • Advanced Solid Tumors - No Longer Enrolling
  • Gastric Cancer - No Longer Enrolling
  • Transitional Cell Carcinoma of the Genitourinary Tract (Bladder Cancer)

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 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Medical Lead

Role: Study Director

Affiliation: Five Prime Therapeutics, Inc.

Overall Contact

Name: Medical Lead

Phone:

Email: FPA144@fiveprime.com

Locations

Facility Status Contact
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay
San Francisco, California 74158
United States
Recruiting
Innovative Cancer Research Institute
Whittier, California 90603
United States
Not yet recruiting Stephen Huang, MD

The University of Chicago Medical Center
Chicago, Illinois 60637
United States
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting
Weill Cornell Medical Center
New York, New York 10065
United States
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Recruiting
Sarah Cannon Research Institute, LLC
Nashville, Tennessee 37203
United States
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030-4009
United States
Recruiting
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
United States
Recruiting
Fairfax Northern VA Hematology Oncology
Fairfax, Virginia 22031
United States
Not yet recruiting
Chonbuk National University Hospital
Jeonju-si, 561-712
Korea, Republic of
Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Korea, Republic of
Recruiting
Seoul National University Hospital
Seoul, 110-744
Korea, Republic of
Recruiting
Severance Hospital, Yonsei University
Seoul, 120-752
Korea, Republic of
Recruiting
Samsung Medical Center
Seoul, 135-710
Korea, Republic of
Recruiting
Gangnam Severance Hospital
Seoul, 135-720
Korea, Republic of
Recruiting
Korea University Anam Hospital
Seoul, 136-705
Korea, Republic of
Recruiting
Seoul St. Mary's Hospital
Seoul, 137-701
Korea, Republic of
Recruiting
SMG-SNU Boramae Medical Center
Seoul, 156-707
Korea, Republic of
Recruiting
China Medical University Hospital
Taichung, 40447
Taiwan
Recruiting
National Cheng Kung University Hospital
Tainan, 704
Taiwan
Recruiting
National Taiwan University Hospital
Taipei, 100
Taiwan
Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Recruiting