Safety Study of FP-1039 To Treat Cancer

This study is currently recruiting participants.

Verified by Five Prime Therapeutics, Inc., February 2010

First Received: May 27, 2008 Last Updated: February 10, 2010 History of Changes

Sponsor:	Five Prime Therapeutics, Inc.
Collaborator:	Parexel
Information provided by:	Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00687505

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 I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled 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

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 ]

Estimated Enrollment:	25
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Single ascending doses	Drug: FP-1039 Intravenous weekly administration

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687505

Locations

United States, Michigan
Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
Contact: Taylor Prokop 313-576-8096 prokopt@karmanos.org
Contact: Mary O'Loughlin 313-578-4405 oloughl@karmanos.org
Principal Investigator: Patricia M. LoRusso, DO
United States, Texas
START (South Texas Accelerated Research Therapeutics)	Recruiting
San Antonio, Texas, United States, 78229
Contact: Tracy Dufresne 210-593-5265 tracy.dufresne@start.stoh.com
Principal Investigator: Anthony W Tolcher, MD

Sponsors and Collaborators

Five Prime Therapeutics, Inc.

Parexel

More Information

No publications provided

Responsible Party:	Five Prime Therapeutics, Inc. ( Harold Keer, MD, PhD. )
ClinicalTrials.gov Identifier:	NCT00687505 History of Changes
Other Study ID Numbers:	FP1039-001
Study First Received:	May 27, 2008
Last Updated:	February 10, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on August 31, 2010