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OpenTrials
Completed

NCT Number: NCT00977210

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRUK Investigational Site, Manchester, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Sponsors and collaborators

Lead sponsor

Mateon Therapeutics

Industry

Collaborators

  • Cancer Research UK

Registry information

Official study title

A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.

Important dates

Study start
2005
Primary completion
2010
First posted
Sep 15, 2009
Registry last updated
Oct 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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