Status:
TERMINATED
This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients. ...
Detailed Description
The study was prematurely terminated on 26Jul2011 due to the undesirable PK characteristics of PF-03758309 and the lack of an observed dose-response relationship. There were no safety concerns that co...
Eligibility Criteria
Inclusion
- Advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
- ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) must be 0 or 1.
- Adequate bone marrow, liver and kidney function.
Exclusion
- Patients with known brain metastases.
- Previous high dose chemotherapy requiring stem cell rescue.
- Prior irradiation to \>25% of the bone marrow.
- Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV).
- Current active treatment in another clinical study.
- Pregnancy or breast feeding.
- Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00932126
Start Date
September 1 2009
End Date
December 1 2011
Last Update
October 28 2015
Active Locations (3)
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1
Pfizer Investigational Site
Santa Monica, California, United States, 90404
2
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
3
Pfizer Investigational Site
East Melbourne, Victoria, Australia, 3002