Solid Tumors Clinical Trial
Official title:
A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.
NCT number | NCT00977210 |
Other study ID # | PH1/098 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | September 14, 2009 |
Last updated | October 28, 2011 |
Start date | July 2005 |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | CRUK Investigational Site | Manchester | |
United Kingdom | CRUK Investigational Site | Middlesex |
Lead Sponsor | Collaborator |
---|---|
OXiGENE | Cancer Research UK |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions. | 4 weeks | Yes | |
Secondary | To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503. | 4 weeks | Yes |
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