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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00977210
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : October 31, 2011
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Mateon Therapeutics

Tracking Information
First Submitted Date  ICMJE September 14, 2009
First Posted Date  ICMJE September 15, 2009
Last Update Posted Date October 31, 2011
Study Start Date  ICMJE July 2005
Actual 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503. [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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. doi: 10.1158/1078-0432.CCR-11-2414. 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
 (submitted: September 14, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00977210
Other Study ID Numbers  ICMJE PH1/098
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mateon Therapeutics
Study Sponsor  ICMJE Mateon Therapeutics
Collaborators  ICMJE Cancer Research UK
Investigators  ICMJE Not Provided
PRS Account Mateon Therapeutics
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP