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

Nerviano Medical Sciences

Status and phase

Terminated

Phase 1

Conditions

Advanced/Metastatic Solid Tumors

Treatments

Drug: PHA-793887

Study type

Interventional

Funder types

Industry

Identifiers

NCT00996255

CDKC-887-001

EudraCT Number: 2006-002149-35

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.