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.
Cancer Research UK
Information provided by (Responsible Party):
First received: September 14, 2009
Last updated: October 28, 2011
Last verified: October 2011
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.
|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 ]
|Study Start Date:||July 2005|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
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.
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