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Safety Study of FP-1039 To Treat Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00687505
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : March 6, 2013
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: FP-1039 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Single ascending doses
 Drug: FP-1039
Intravenous weekly administration


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00687505    
Other Study ID Numbers: FP1039-001
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013