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

Phase 1

Terminated

• Conditions: Advanced/Metastatic Solid Tumors
• Interventions: Drug: PHA-793887

• Registration Number: NCT00996255
• Lead Sponsor: Nerviano Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2009-10
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-15
• Last Update Submitted: 2009-10-15
• Study First Posted: 2009-10-16
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose-Escalation	PHA-793887	-

Primary Outcome Measures

Name	Time	Method
Determination of Dose Limiting Toxicities and Maximum Tolerated Dose	First cycle

Secondary Outcome Measures

Name	Time	Method
Assessment of Adverse Events (based on CTCAE version 3.0)	All cycles
Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters.	First 2 cycles
Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment.	First cycle

Trial Locations

Locations (2)

St. James University Hospital; 🇬🇧 Leeds, United Kingdom

Institut Gustave-Roussy; 🇫🇷 Villejuif Cedex, France