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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.

Tracking Information
First Submitted Date  ICMJE May 27, 2008
First Posted Date  ICMJE May 30, 2008
Last Update Posted Date March 6, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2008)
Safety and tolerability [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of FP-1039 To Treat Cancer
Official Title  ICMJE 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
Brief Summary The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a new biologic treatment for cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Drug: FP-1039
Intravenous weekly administration
Study Arms  ICMJE Experimental: 1
Single ascending doses
Intervention: Drug: FP-1039
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2011)
39
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2008)
25
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00687505
Other Study ID Numbers  ICMJE FP1039-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Five Prime Therapeutics, Inc.
Study Sponsor  ICMJE Five Prime Therapeutics, Inc.
Collaborators  ICMJE Parexel
Investigators  ICMJE Not Provided
PRS Account Five Prime Therapeutics, Inc.
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP