Safety Study of FP-1039 To Treat Cancer

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

Tracking Information

• First Submitted Date: May 27, 2008
• First Posted Date: May 30, 2008
• Last Update Posted Date: March 6, 2013
• Study Start Date: July 2008
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 27, 2008): Safety and tolerability [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of FP-1039 To Treat Cancer
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Cancer

Intervention

Drug: FP-1039

Intravenous weekly administration

Study Arms

Experimental: 1

Single ascending doses

Intervention: Drug: FP-1039

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 6, 2011): 39
• Original Estimated Enrollment (submitted: May 27, 2008): 25
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00687505
• Other Study ID Numbers: FP1039-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Five Prime Therapeutics, Inc.
• Study Sponsor: Five Prime Therapeutics, Inc.
• Collaborators: Parexel
• Investigators: Not Provided
• PRS Account: Five Prime Therapeutics, Inc.
• Verification Date: March 2013