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Safety Study of FP-1039 To Treat Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00687505
First Posted: May 30, 2008
Last Update Posted: March 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Parexel
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.
  Purpose
The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a new biologic treatment for cancer.

Condition Intervention Phase
Advanced Cancer Drug: FP-1039 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Five Prime Therapeutics, Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 4 weeks ]

Enrollment: 39
Study Start Date: July 2008
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single ascending doses
Drug: FP-1039
Intravenous weekly administration

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687505


Locations
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Texas
START (South Texas Accelerated Research Therapeutics)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Parexel
  More Information

Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00687505     History of Changes
Other Study ID Numbers: FP1039-001
First Submitted: May 27, 2008
First Posted: May 30, 2008
Last Update Posted: March 6, 2013
Last Verified: March 2013