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CompletedNCT00977210Updated Oct 31, 2011

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

A Phase 1 interventional study of OXi4503 in Solid Tumors, sponsored by Mateon Therapeutics. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-31.

Sponsored by Mateon Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumors

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Keywords

  • Phase 1
  • oxi4503
  • oxigene
  • cruk
  • solid tumors
  • VDA
  • vascular disrupting agent
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Mateon Therapeutics is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    OXi4503

    Drug: OXi4503

Interventions

  • DrugOXi4503

    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.

06

What researchers measure

Primary outcomes

  1. To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.

    Time frame: 4 weeks

Secondary outcomes

  1. To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503.

    Time frame: 4 weeks

07

Study locations

2 sites
  • CRUK Investigational Site
    Manchester, United Kingdom
  • CRUK Investigational Site
    Middlesex, United Kingdom
08

References and documents

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. doi: 10.1158/1078-0432.CCR-11-2414. Epub 2012 Jan 10. PubMed 22235096 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00977210
Lead sponsor
Mateon Therapeutics
Collaborators
Cancer Research UK
Responsible party
Sponsor
First posted
Sep 15, 2009
Start date
Jul 2005
Primary completion
Sep 2010
Last update
Oct 31, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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