Safety Study of FP-1039 To Treat Cancer

December 9, 2021 updated by: Five Prime Therapeutics, Inc.

A Phase 1, Open-Label, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of FP-1039 in Subjects With Metastatic or Locally Advanced Unresectable Solid Tumors

The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a new biologic treatment for cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Texas
      • San Antonio, Texas, United States, 78229
        • START (South Texas Accelerated Research Therapeutics)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with metastatic or locally advanced unresectable solid tumors for which standard curative or supportive measures do not exist or are no longer effective
  • Male or female 18 years of age or older

Exclusion Criteria:

  • Presence or history of melanoma
  • Primary brain tumor
  • Presence or history of glaucoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Single ascending doses
Drug: FP-1039
Intravenous weekly administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Five Prime Therapeutics, Inc.

Collaborators

Parexel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 30, 2008

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • FP1039-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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