NCT01147029

GSAO in Treating Patients With Advanced Solid Tumors That Have Not Responded to Therapy

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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. Tertiary * 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	angiogenesis inhibitor GSAO
OTHER	laboratory biomarker analysis
OTHER	pharmacological study
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-06-22
• Last updated: 2012-05-01

Locations

2 sites across 1 country: United Kingdom