Safety Study of FP-1039 To Treat Cancer

• Sponsor: Five Prime Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00687505
• Collaborator: Parexel (Industry)
• Enrollment: 39
• Locations: 2
• Arm: 1
• Duration (Months): 35
• Patients Per Site: 19.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jul 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Single ascending doses	Drug: FP-1039; Intravenous weekly administration

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
2	START (South Texas Accelerated Research Therapeutics)	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Five Prime Therapeutics, Inc.
• Parexel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Five Prime Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT00687505
• Other Study ID Numbers: FP1039-001
• First Posted: May 30, 2008
• Last Update Posted: Dec 13, 2021
• Last Verified: Dec 1, 2021

Study Results

No Results Posted as of Dec 13, 2021