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:
OXiGENE
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: OXi4503 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors. |
Resource links provided by NLM:
Further study details as provided by OXiGENE:
Primary Outcome Measures:
- To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2005 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: OXi4503 |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
Additional Information:
No publications provided by OXiGENE
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | OXiGENE |
| ClinicalTrials.gov Identifier: | NCT00977210 History of Changes |
| Other Study ID Numbers: | PH1/098 |
| Study First Received: | September 14, 2009 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United Kingdom: Department of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service |
Keywords provided by OXiGENE:
|
Phase 1 oxi4503 oxigene cruk |
solid tumors VDA vascular disrupting agent |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013