A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-04449913, An Oral Hedgehog Inhibitor, Administered As Single Agent In Select Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Tumors
Both
Solid Tumors
Trial Information
A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-04449913, An Oral Hedgehog Inhibitor, Administered As Single Agent In Select Solid Tumors
Inclusion Criteria:
- Histological or cytological diagnosis of advanced/metastatic solid tumor
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
Exclusion Criteria:
- Patients with known symptomatic brain metastases requiring steroids
- Current active treatment on another clinical trial
- Major surgery or radiation therapy within 4-weeks of starting study treatment
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
First cycle dose limiting toxicities (DLTs)
Outcome Time Frame:
10 months
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
B1371002
NCT ID:
NCT01286467
Start Date:
May 2011
Completion Date:
December 2012
Related Keywords:
- Solid Tumors
- PF-04449913
- Hedgehog Inhibitor
- Solid tumor
- Pharmacokinetics
- Safety
- Pharmacodynamics
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Aurora, Colorado 80012 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
