Tolerability Study of Investigational Agent, ARRY-520, in Subjects With Cancer

This study is currently recruiting participants.

Verified by Array BioPharma, May 2008

Sponsored by:	Array BioPharma
Information provided by:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00462358

Purpose

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ARRY-520 in subjects with solid tumors refractory to, or ineligible for, standard therapy(ies) and to determine the maximum tolerated dose.

Condition	Intervention	Phase
Neoplasms	Drug: ARRY-520	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Phase I Safety and Pharmacokinetic Study of ARRY-520 in Solid Tumors

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

Safety and tolerability of ARRY-520 [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	April 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological or cytological evidence of malignancy
Advanced solid tumors that have recurred or progressed following standard therapy
Subject is considered refractory to or ineligible for standard therapy
ECOG performance status between 0-2
Additional inclusion criteria may apply

Exclusion Criteria:

Treatment with an Investigational Product or Device, or anti-neoplastic therapy (with the exclusion of hormone therapy where the therapy will continue at a standard dose throughout the study) within 28 days of initiating study drug
Major surgery within 28 days prior to first dose of study drug
Radiotherapy within 28 days prior to first dose of study drug
Any severe concurrent disease or condition, which, in the judgment of the Investigator, would make the subject inappropriate for study participation
Known positive serology for HIV, Hepatitis B and/or Hepatitis C
Additional exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462358

Locations

United States, Maryland
Marlene and Stewart Greenbaum Cancer Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Judith A Carter, RN 410-328-3999 jcarter1@umm.edu
Principal Investigator: Edward Sausville, MD
United States, Michigan
Wayne State University, Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
Contact: Patricia LoRusso, DO 313-576-8749 lorussop@karmanos.org
Principal Investigator: Patricia LoRusso, DO

Sponsors and Collaborators

Array BioPharma

More Information

Responsible Party:	Array BioPharma ( Dale Roseberry, Senior Clinical Program Manager )
Study ID Numbers:	ARRAY-520-101
Study First Received:	April 18, 2007
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00462358
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009