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

This study has been completed.

Sponsor:

Collaborator:

Cancer Research UK

Information provided by (Responsible Party):

OXiGENE

ClinicalTrials.gov Identifier:

NCT00977210

First received: September 14, 2009

Last updated: October 28, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 14, 2009
Last Updated Date	October 28, 2011
Start Date ^ICMJE	July 2005
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2009)	To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00977210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 14, 2009)	To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
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	Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors
Official Title ^ICMJE	A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.
Brief Summary	The purpose of this study is to establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly infusions to patients with advanced solid tumors.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Solid Tumors
Intervention ^ICMJE	Drug: OXi4503 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.
Study Arm (s)	Experimental: OXi4503 Intervention: Drug: OXi4503
Publications *	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. Epub 2012 Jan 10.
* 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	Completed
Estimated Enrollment ^ICMJE	40
Completion Date	Not Provided
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00977210
Other Study ID Numbers ^ICMJE	PH1/098
Has Data Monitoring Committee	No
Responsible Party	OXiGENE
Study Sponsor ^ICMJE	OXiGENE
Collaborators ^ICMJE	Cancer Research UK
Investigators ^ICMJE	Not Provided
Information Provided By	OXiGENE
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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