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

NCT ID: NCT00996255

Last Updated: 2009-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-02-29

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. 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.

Conditions

Advanced/Metastatic Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose-Escalation

Group Type: EXPERIMENTAL

PHA-793887

Intervention Type: DRUG

Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.

Interventions

PHA-793887

Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nerviano Medical Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Nerviano Medical Sciences

Principal Investigators

Jean-Charles Soria, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Institut Gustave-Roussy, Villejuif Cedex, France

Chris Twelves, MD Professor

Role: PRINCIPAL_INVESTIGATOR

St James University Hospital, Leeds, UK

Locations

Institut Gustave-Roussy

Villejuif, , France

St. James University Hospital

Leeds, , United Kingdom

Countries

France; United Kingdom

Other Identifiers

EudraCT Number: 2006-002149-35

Identifier Type: -

Identifier Source: secondary_id

CDKC-887-001

Identifier Type: -

Identifier Source: org_study_id