Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Andrew Ko

Description

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.

Official Title

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

Details

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.

Keywords

Advanced Solid Tumors - No Longer Enrolling Gastric Cancer - No Longer Enrolling Transitional Cell Carcinoma of the Genitourinary Tract (Bladder Cancer) - No Longer Enrolling FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer Stomach Neoplasms Urinary Bladder Neoplasms Carcinoma, Transitional Cell FPA144

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay
    San Francisco California 74158 United States
  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States
  • City of Hope Comprehensive Cancer Center
    Duarte California 91010 United States
  • Innovative Cancer Research Institute
    Whittier California 90603 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Five Prime Therapeutics, Inc.
ID
NCT02318329
Phase
Phase 1
Lead Scientist
Andrew Ko
Study Type
Interventional
Last Updated
April 6, 2018