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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
Not Enrolling
Both
Advanced Cancer

Thank you

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 InstituteDetroit, Michigan  48201
START (South Texas Accelerated Research Therapeutics)San Antonio, Texas  78229