A Phase 1, Open-Label, Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CHIR-265 Administered Orally to Subjects With Locally Advanced or Metastatic Melanoma

Status
Active
Cancer Type
Melanoma
Trial Phase
Phase I
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT00304525
Protocol IDs
CHIR-265-MEL01 (primary)
CHIRON-265-MEL01
CHIRON-CHIR-265-MEL01
UPCC-03605
UPCC-804245
Study Sponsor
Chiron Therapeutics

Summary

The purpose of this study is to determine the safety profile, pharmacokinetics, pharmacodynamics and maximum tolerated dose of CHIR-265 in patients with locally advanced and metastatic melanoma.

Objectives

The Ras/Raf/MEK/ERK pathway plays a prominent role in controlling several key cellular functions including growth, proliferation and survival. B-Raf is a member of the Ras/Raf/MEK/ERK pathway and is frequently mutated in melanoma resulting in activation of the MAPK pathway. CHIR-265 is a novel, orally active, small molecule with potent inhibitory activity against B-Raf kinase and additional antiangiogenic activity through inhibition of vascular endothelial growth factor receptor type 2 (VEGFR-2) in non-clinical studies.

The primary objectives of this study are to determine the maximum tolerated dose (MTD), dose limiting toxicities (DLTs), and the safety profile of CHIR-265 when administered orally to subjects with locally advanced or metastatic melanoma; to determine the plasma pharmacokinetics (PK) of orally administered CHIR-265; and to evaluate potential pharmacodynamic effects of CHIR-265 using tumor biopsies, peripheral blood samples, and tumor imaging.

Treatment Sites in Georgia


Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

Study Coordinator:
Pam Bourbo
706-721-7230