This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors
| Status: | Terminated |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | December 2011 |
Phase 1, Open Label, Dose-Escalation, Safety, Pharmacokinetic And Pharmacodynamic Study Of Single Agent PF-03758309, An Oral PAK4 Inhibitor, In Patients With Advanced Solid Tumors
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.
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.
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 contributed to the study termination.
of PF-03758309 and the lack of an observed dose-response relationship. There were no safety
concerns that contributed to the study termination.
Inclusion Criteria:
- 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 Criteria:
- 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.
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