Dose-Escalation Study of PHA-793887 in Patients With Advanced/Metastatic Solid Tumors

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nerviano Medical Sciences

Criteria

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.