NCT00977210

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2011

Enrollment Period

5.2 years

First QC Date

September 14, 2009

Last Update Submit

October 28, 2011

Conditions

Solid Tumors

Keywords

Phase 1oxi4503oxigenecruksolid tumorsVDAvascular disrupting agent

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (1)

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

    4 weeks

Study Arms (1)

OXi4503

EXPERIMENTAL
Drug: OXi4503

Interventions

OXi4503DRUG

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.

OXi4503

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CRUK Investigational Site

Manchester, United Kingdom

Location

CRUK Investigational Site

Middlesex, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22235096DERIVED

MeSH Terms

Interventions

Oxi 4503

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 15, 2009

Study Start

July 1, 2005

Primary Completion

September 1, 2010

Last Updated

October 31, 2011

Record last verified: 2011-10

Locations

GB(2)