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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Advanced Cancer
Both
Advanced Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability
Outcome Time Frame:
4 weeks
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
FP1039-001
NCT ID:
NCT00687505
Start Date:
July 2008
Completion Date:
June 2011
Related Keywords:
- Advanced Cancer
- Neoplasms
Name | Location |
|---|---|
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| START (South Texas Accelerated Research Therapeutics) | San Antonio, Texas 78229 |
