Tolerability Study of Investigational Agent, ARRY-142886, in Patients With Cancer

This study has been completed.

First Received: June 14, 2004 Last Updated: March 24, 2009 History of Changes

Sponsor:	Array BioPharma
Information provided by:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00085787

Purpose

The purpose of this study is to assess the tolerability of ARRY-142886 in patients with advanced solid malignancies that have failed standard therapy or for whom no standard therapy exists and determine the maximum tolerated dose as defined by significant dose limiting toxicity.

Condition	Intervention	Phase
Cancer	Drug: ARRY-142886	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Pharmacokinetics/Dynamics Study
Official Title:	A Phase I, Open-Label, Multiple Dose Study to Assess the Tolerability, Pharmacokinetics and Pharmacodynamics of ARRY-142886 Given on a Daily Oral Regime in Subjects With Advanced Solid Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: ARRY 142886

U.S. FDA Resources

Eligibility

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

Criteria

Inclusion Criteria:

Confirmed solid tumor which is refractory to standard therapies
At least 18 years old
Ambulatory with ECOG status of 0-2
Life expectancy of greater than or equal to 3 months

Exclusion Criteria:

Brain metastases
Use of investigational medication or device within 30 days
Major surgery within 30 days
Radiotherapy or chemotherapy within 21 days
Pregnant or lactating
Known positive for HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085787

Locations

United States, Colorado
University of Colorado Cancer Center, Anschutz Cancer Center
Aurora, Colorado, United States, 80010
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111

Sponsors and Collaborators

Array BioPharma

More Information

No publications provided

Study ID Numbers:	ARRY-0401
Study First Received:	June 14, 2004
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00085787 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 09, 2009