Dose-Escalation Study of PHA-793887 in Patients With Adva... | NCT00996255

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

NCT00996255

Sponsor

Nerviano Medical Sciences

Status

Terminated

Last Update Posted

Oct 16, 2009Estimated

Enrollment

19Actual

Phase

Phase 1

Conditions

Advanced/Metastatic Solid Tumors

Interventions

PHA-793887

Countries

France
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT Number: 2006-002149-35

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Oct 14, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2009

Last Update Posted Date

Oct 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Label	Type	Description	Intervention Names
Dose-Escalation	Experimental		Drug: PHA-793887

Name	Type	Description	Arm Group Labels	Other Names
PHA-793887	Drug	Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.	Dose-Escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of Dose Limiting Toxicities and Maximum Tolerated Dose		First cycle

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave-Roussy		Villejuif		94805	France
St. James University Hospital