GSAO in Treating Patients With Advanced Solid Tumors That Have Not Responded to Therapy
|ClinicalTrials.gov Identifier: NCT01147029|
Recruitment Status : Terminated (Sponsor Decision)
First Posted : June 22, 2010
Last Update Posted : May 1, 2012
RATIONALE: GSAO may stop the growth of solid tumors by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of GSAO in treating patients with advanced solid tumors that have not responded to therapy.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: angiogenesis inhibitor GSAO Other: laboratory biomarker analysis Other: pharmacological study Procedure: dynamic contrast-enhanced magnetic resonance imaging||Phase 1|
- To determine the maximum-tolerated dose and recommended phase II dose of angiogenesis inhibitor GSAO in patients with advanced, refractory solid tumors.
- To assess the safety and toxicity profile and dose-limiting toxicity of this drug in these patients.
- To determine the pharmacokinetics of this drug in these patients.
- To determine the pharmacodynamics of this drug in these patients.
- To determine possible anti-tumor activity in patients treatment with this drug.
- To further determine the pharmacodynamics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive angiogenesis inhibitor GSAO IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients showing clinical benefit (i.e., stable disease, partial response, or complete response) may receive 6 additional courses of treatment. Patients receive angiogenesis inhibitor GSAO IV over 1 hour on day -7 to obtain pharmacokinetics information of a single IV dose of the drug.
Patients also undergo dynamic contrast-enhanced magnetic-resonance imaging (DCE-MRI) prior to, during, and after study to determine blood flow parameters.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and biomarker studies.
After completion of study treatment, patients are followed up for 28 days and then once a month thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Official Title:||A Cancer Research UK Phase I Trial of 4-(N-(S-Glutathionylacetyl) Amino) Phenylarsenoxide (GSAO) Given as Daily Intravenous Infusions on Days 1-5 and 8-12 of a 21-Day Cycle, to Patients With Advanced Solid Tumors|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
- Dose-limiting toxicity
- Causality of each adverse event and grading severity according to NCI CTCAE Version 3.0
- Relationship between pharmacokinetics and toxicity and/or markers of efficacy
- Changes in microvascular function using DCE-MRI
- Plasma and tumor levels of angiogenic factors and apoptosis markers
- Response (stable disease, partial response, or complete response) as determined by RECIST criteria
- Circulating endothelial cells and circulating endothelial progenitor cells as a marker of inhibition of angiogenesis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147029
|Manchester, England, United Kingdom, M20 4BX|
|Oxford, England, United Kingdom, OX3 7LJ|
|Principal Investigator:||Gordon Jayson, MD||The Christie NHS Foundation Trust|