A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors
Inclusion Criteria:
- Advanced/metastatic solid tumors for which no standard therapy exists
- ECOG (WHO) performance status 0-1
- Life expectancy of at least 3 months
- Age ≥ 18 years
- Adequate liver, pancreas and renal function
- Acceptable hematologic status
- Acute toxic effects from prior therapy must be resolved to NCI CTCAE Grade ≤ 1
- Treatment with surgery, chemotherapy, or investigational therapy must be completed at
least one month prior to treatment initiation (6 weeks for nitrosoureas or Mitomycin
C and liposomal doxorubicin)
- Prior radiation therapy allowed in no more than 25% of bone marrow reserve
- Men and women of child-producing potential must agree upon the use of effective
contraceptive methods
Exclusion Criteria:
- In the past 6 months: myocardial infarction, unstable angina, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident
or transient ischemic attack, pulmonary embolism, deep vein thrombosis
- Known brain metastases
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy
- Pregnant or breast feeding women
- Known infection with HIV, active hepatitis B or hepatitis C
- Patients who have exhibited allergic reactions to a similar structural compound,
biological agent, or formulation
- History of pancreatitis or disorders making the patient at risk of pancreatitis
- Previous history or current presence of neurological disorders
- Patients with pre-existing symptoms of peripheral neuropathy not related to prior
anticancer therapy(ies)
- Concomitant treatment that may be associated with peripheral neuropathy
- Other severe concurrent conditions that could compromise protocol objectives.