Safety Study of FP-1039 To Treat Cancer
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
1 other identifier
interventional
39
1 country
2
Brief Summary
The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a new biologic treatment for cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2008
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 30, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 13, 2021
December 1, 2021
2.8 years
May 27, 2008
December 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
4 weeks
Study Arms (1)
1
EXPERIMENTALSingle ascending doses
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence or history of melanoma
- Primary brain tumor
- Presence or history of glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Five Prime Therapeutics, Inc.lead
- Parexelcollaborator
Study Sites (2)
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
START (South Texas Accelerated Research Therapeutics)
San Antonio, Texas, 78229, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 30, 2008
Study Start
July 1, 2008
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
December 13, 2021
Record last verified: 2021-12