Clinical Trial: A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: This is a Phase 1 study during which patients with advanced cancer will receive investigational study drug ARRY-382. Patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in this study.

Detailed Summary:
Sponsor: Array BioPharma

Current Primary Outcome:

  • Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year. ]
  • Establish the maximum tolerated dose (MTD) of study drug. [ Time Frame: The MTD will be based on Cycle 1 (28 days). ]
  • Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites. [ Time Frame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year. ]


Original Primary Outcome:

  • Characterize the safety profile as determined by adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year. ]
  • Establish the maximum tolerated dose (MTD) of study drug. [ Time Frame: The MTD will be based on Cycle 1 (28 days). ]
  • Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites. [ Time Frame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year. ]


Current Secondary Outcome: Assess the efficacy of study drug in terms of incidence of response rate and duration of response. [ Time Frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated one year. ]

Original Secondary Outcome:

  • Assess the dosing schedule(s) for study drug. [ Time Frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated one year. ]
  • Assess the efficacy of study drug in terms of incidence of response rate and duration of response. [ Time Frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated one year. ]


Information By: Array BioPharma

Dates:
Date Received: December 1, 2010
Date Started: March 2011
Date Completion:
Last Updated: October 23, 2012
Last Verified: October 2012