Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of PF-4217903 in Patients With Advanced Cancer
18 Years
N/A
Both
Neoplasms
Trial Information
Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of PF-4217903 in Patients With Advanced Cancer
The study was prematurely discontinued due to a strategic development decision by Pfizer on
10FEB2012. The decision to terminate was not based on any safety concerns.
Inclusion Criteria:
- Advanced solid tumors, histologically proven at diagnosis which is refractory to
standard of care or for whom no standard of care therapy is available
- Adequate blood cell counts, normal kidney function, and performance status of 0 or 1
Exclusion Criteria:
- Major surgery, radiation therapy or anti-cancer therapy within 2 weeks of starting
study treatment
- Prior stem cell transplant
- Active or unstable cardiac disease or heart attack within 12 months of starting study
treatment
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD)
Outcome Description:
MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities.
Outcome Time Frame:
Baseline up to 21 days after the start of each increased treatment dose
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:
B0331002
NCT ID:
NCT00706355
Start Date:
August 2008
Completion Date:
June 2011
Related Keywords:
- Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Aurora, Colorado 80012 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
