This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
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. The study will assess the compound's safety, the blood levels of PF-03758309 during the treatment and the effect of the compound on the tumor cells.
Key facts
- Study ID
- NCT00932126
- Run by
- Pfizer
- People needed
- 35
- Starts
- 2009-09-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2015-10-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Santa Monica, California, United States
- Pfizer Investigational Site — Aurora, Colorado, United States
- Pfizer Investigational Site — East Melbourne, Victoria, Australia
Full record on ClinicalTrials.gov
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