NCT02033148

Icotinib Hydrochloride in Treating Patients With Advanced Cancers

A Phase 1 Study to Evaluate the Safety and Pharmacokinetic Profile of Icotinib in Patients With Advanced Cancers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of icotinib hydrochloride in treating patients with advanced cancers. Icotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the pharmacokinetic (PK) profiles of icotinib (icotinib hydrochloride) in patients with advanced cancers. II. To determine the safety, tolerability and maximum tolerated dose (MTD) of icotinib in patients with advanced cancers. SECONDARY OBJECTIVES: I. To preliminarily assess the anti-tumor activity of icotinib in patients with advanced cancers. II. To characterize the effect, if any, of icotinib on corrected QT interval using Bazett's formula (QTcB). TERTIARY OBJECTIVES: I. To evaluate single nucleotide polymorphisms in genes encoding for icotinib's target (epidermal growth factor receptor \[EGFR\]), putative transport protein (ATP-binding cassette, sub-family G \[WHITE\], member 1 \[ABCG1\]) and major metabolizing enzyme (cytochrome P450 3A4 \[CYP3A4\]) as well as other genes that may be found to be important in icotinib activity, and correlate these single nucleotide polymorphisms (SNPs) with clinical activity and toxicity. OUTLINE: This is a dose-escalation study. Patients receive icotinib hydrochloride orally (PO) twice daily (BID) on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	icotinib hydrochloride	Given PO
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-06-01
• First posted: 2014-01-10
• Last updated: 2014-11-05