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

This study is ongoing, but not recruiting participants.
Study NCT00085787.   Last updated on July 12, 2007.   Information provided by Array BioPharma

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Descriptive Information Fields
Brief Title  Tolerability Study of Investigational Agent, ARRY-142886, in Patients With Cancer
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
Brief Summary

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.

Detailed Description
Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Open Label, Pharmacokinetics/Dynamics Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cancer
Intervention  Drug: ARRY-142886
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date 
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00085787
Organization ID ARRY-0401
Secondary IDs ††
Study Sponsor  Array BioPharma
Collaborators ††
Investigators 
Information Provided By Array BioPharma
Verification Date July 2007
First Received Date  June 14, 2004
Last Updated Date July 12, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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