Safety Study of OXi4503 (a Vascular Disrupting Agent) Giv... | NCT00977210

Studies
Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors

NCT00977210

Sponsor

Mateon Therapeutics

Status

Completed

Last Update Posted

Oct 31, 2011Estimated

Enrollment

40Estimated

Phase

Phase 1

Conditions

Solid Tumors

Interventions

OXi4503

Countries

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

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Sep 2010Actual

Completion Date

Not provided

First Submitted Date

Sep 14, 2009

First Submission Date that Met QC Criteria

Sep 14, 2009

First Posted Date

Sep 15, 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 28, 2011

Last Update Posted Date

Oct 31, 2011Estimated

Name	Class
Cancer Research UK	OTHER

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

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

40Estimated

Label	Type	Description	Intervention Names
OXi4503	Experimental		Drug: OXi4503

Name	Type	Description	Arm Group Labels	Other Names
OXi4503	Drug	OXi4503 will be administered weekly for 3 weeks followed by a week with no treatment. The starting dose will be 0.06 mg/m2 given as an intravenous infusion over 10 minutes.

Measure	Description	Time Frame
To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.		4 weeks

Measure	Description	Time Frame
To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503.		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven cancer.
Written informed consent.
Age >/= 18 years.
Life expectancy of at least 12 weeks.
World Health Organization (WHO) performance status of 0 or 1.
Adequate Hematological and biochemical indices to support investigational therapy.
All women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
WOCBP and fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days after the last dose of study medication.
Measurable and evaluable disease.
All toxic manifestations of previous treatment must have resolved.
Able to undergo MRI scanning.

Exclusion Criteria:

Radiotherapy, endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) prior to treatment.
Pregnant and lactating women.
Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
Patients which have active uncontrolled infections.
Patients with any other condition that in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
Previous or ongoing cardiac conditions.
Uncontrolled hypertension.
Patients taking any drug known to prolong the QTc interval.
Patients who have had any ischaemic or vascular damage from previous radiotherapy.
Patients taking warfarin or heparin.
Patients taking naproxen.
Patients taking supplements or multivitamins containing vitamin C.
Patients should not be taking any other investigational drug for the duration of the study.
Patients with brain metastases or neurological tissue involvement of the spinal column.

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

Facility	Status	City	State	ZIP	Country	Contacts
CRUK Investigational Site		Manchester			United Kingdom
CRUK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22235096	Derived	Patterson DM, Zweifel M, Middleton MR, Price PM, Folkes LK, Stratford MR, Ross P, Halford S, Peters J, Balkissoon J, Chaplin DJ, Padhani AR, Rustin GJ. Phase I clinical and pharmacokinetic evaluation of the vascular-disrupting agent OXi4503 in patients with advanced solid tumors. Clin Cancer Res. 2012 Mar 1;18(5):1415-25. doi: 10.1158/1078-0432.CCR-11-2414. Epub 2012 Jan 10.