A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies
Inclusion Criteria:
- Patients with advanced non-hematologic malignancies.
- Adequate organ function, including bilirubin less than 1.5 x ULN, and ECOG (Eastern
Cooperative Oncology Group) performance status of 0-2.
Exclusion Criteria:
- Clinically significant gastrointestinal abnormalities, requirement for systemic
anticoagulants or potent CYP 2C8 inhibitors, and history of clinically significant
cardiac or pulmonary disorders
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recommended Phase 2 Dose
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
B0761001
NCT ID:
NCT00787033
Start Date:
December 2008
Completion Date:
February 2012
Related Keywords:
- Cancer
- Focal Adhesion Kinase; Advanced Non-Hematologic Malignancies
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
