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A Phase 1 Study of ARRY-438162 in Patients With Advanced Solid Tumors Followed by an Expansion Cohort in Patients With Advanced or Metastatic Biliary Cancer

2014-08-27 03:20:02 | BioPortfolio

Summary

This is the first part of a 2-part study to assess the safety, tolerability, and pharmacokinetics of ARRY-438162 in patients with advanced solid tumors. This first part is an open-label dose escalation study to establish the maximum tolerated dose of ARRY-438162.

The second part, expansion at maximum tolerated dose (MTD), is designed to assess the safety, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics (PD) in patients with advanced or metastatic biliary cancer. Approximately 30 patients from the US will be enrolled in Part 1 and approximately 25 patients from the US will be enrolled in Part 2.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Solid Tumors

Intervention

ARRY-438162

Location

University of California, Los Angeles
Los Angeles
California
United States
90095

Status

Recruiting

Source

Array BioPharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:02-0400

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