Status:
TERMINATED
Dose-Escalation Study of PHA-793887 in Patients With Advanced/Metastatic Solid Tumors
Lead Sponsor:
Nerviano Medical Sciences
Conditions:
Advanced/Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00996255
Start Date
November 1 2006
End Date
February 1 2008
Last Update
October 16 2009
Active Locations (2)
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1
Institut Gustave-Roussy
Villejuif, France, 94805
2
St. James University Hospital
Leeds, United Kingdom, LS9 7TF