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Summary

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

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

Solid Tumors Gastric Cancer FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer

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
  • Adequate hematological and organ function, confirmed by lab values
  • Tumor tissue for determination of FGFR2b overexpression and FGFR2 amplification(optional for Part 1A patients)

You CAN'T join if...

  • QTc segment >470 msec
  • Treatment with any anticancer therapy or investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
  • Presence of any condition that may increase the risk associated with study participation or interfere with interpretation of study results

Locations

  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte, California, 91010, United States
  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles, California, 90095, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Five Prime Therapeutics, Inc.
ID
NCT02318329
Phase
Phase 1
Lead Scientist
W. Korn
Study Type
Interventional
Last Updated
January 1, 2017
I’m interested in this study!