A Phase 1 Study Of PF-05212384 (Also Known as PKI-587) Administered As An Intravenous Infusion To Subjects With Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
A Phase 1 Study Of PF-05212384 (Also Known as PKI-587) Administered As An Intravenous Infusion To Subjects With Solid Tumors
Inclusion Criteria:
- Pathologic diagnosis of any solid tumor
- Incurable cancer, with disease progression following at least 1 therapy with no
further standard treatment available in the opinion of the investigator.
- At least 1 evaluable lesion per RECIST criteria
Exclusion Criteria:
- Clinically unstable primary or metastatic CNS tumors
- Subjects with known diabetes
- QTc interval greater than 470 ms.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assessment of Dose Limiting Toxicities (DLTs), Adverse Events (AEs) and Serious Adverse Events (SAEs)
Outcome Time Frame:
1 year
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:
B2151001
NCT ID:
NCT00940498
Start Date:
January 2010
Completion Date:
October 2012
Related Keywords:
- Neoplasms
- Phase 1
- Dose Finding
- Solid Tumors
- Tumors
- PF-05212384
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
