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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

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

September 14, 2009
October 28, 2011
July 2005
September 2010   (final data collection date for primary outcome measure)
To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00977210 on ClinicalTrials.gov Archive Site
To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors
A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
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.
Experimental: OXi4503
Intervention: Drug: OXi4503
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.
 
Completed
40
Not Provided
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00977210
PH1/098
No
OXiGENE
OXiGENE
Cancer Research UK
Not Provided
OXiGENE
October 2011

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