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

This study has been terminated.

Sponsor:

Information provided by:

Nerviano Medical Sciences

ClinicalTrials.gov Identifier:

NCT00996255

First received: October 14, 2009

Last updated: October 15, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2009

Last Updated Date

October 15, 2009

Start Date ^ICMJE

November 2006

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determination of Dose Limiting Toxicities and Maximum Tolerated Dose [ Time Frame: First cycle ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00996255 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of Adverse Events (based on CTCAE version 3.0) [ Time Frame: All cycles ] [ Designated as safety issue: Yes ]
Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters. [ Time Frame: First 2 cycles ] [ Designated as safety issue: No ]
Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment. [ Time Frame: First cycle ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Advanced/Metastatic Solid Tumors

Intervention ^ICMJE

Drug: PHA-793887

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

Study Arm (s)

Experimental: Dose-Escalation

Intervention: Drug: PHA-793887

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00996255

Other Study ID Numbers ^ICMJE

CDKC-887-001, EudraCT Number: 2006-002149-35

Has Data Monitoring Committee

Responsible Party

Clinical Research Head, Nerviano Medical Sciences

Study Sponsor ^ICMJE

Nerviano Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Jean-Charles Soria, MD Professor	Institut Gustave-Roussy, Villejuif Cedex, France
Principal Investigator:	Chris Twelves, MD Professor	St James University Hospital, Leeds, UK

Information Provided By

Nerviano Medical Sciences

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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