Clinical trial NCT00977210: Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors
Official title: A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Phase 1
oxi4503
oxigene
cruk
solid tumors
VDA
vascular disrupting agent
Lead sponsor: Mateon Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Cancer Research UK
First posted: 2009-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.
timeFrame: 4 weeks
Secondary outcomes:
measure: To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: CRUK Investigational Site
city: Middlesex
country: United Kingdom
facility: CRUK Investigational Site
Study officials:
References:
citation: 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.