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Safety Study of FP-1039 To Treat Cancer

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00687505
First received: May 27, 2008
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00687505     History of Changes
Other Study ID Numbers: FP1039-001
Study First Received: May 27, 2008
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013