A Study of ARRY-142886 in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00085787
First received: June 14, 2004
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-142886.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 25 patients from the US will be enrolled in Part 1 (Completed).

In the second part of the study, patients will receive the best dose of study drug, determined from the first part of the study, and will be followed to see what side effects the study drug causes and what effectiveness the study drug has, if any, in treating the cancer. Approximately 35 patients from the US will be enrolled in Part 2 (Completed).


Condition Intervention Phase
Advanced Cancer
Drug: ARRY-142886, MEK inhibitor; oral
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: Part 1 ] [ Designated as safety issue: Yes ]
  • Establish the maximum tolerated dose (MTD) of study drug. [ Time Frame: Part 1 ] [ Designated as safety issue: Yes ]
  • Assess the biological activity of the study drug in tumors in terms of inhibition of extracellular signal-regulated kinase (ERK) phosphorylation. [ Time Frame: Part 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: No ]
  • Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: No ]
  • Assess the efficacy of the study drug in terms of tumor dimension assessment. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: No ]
  • Confirm the safety of the study drug at the MTD as determined by adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: Part 2 ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: June 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-142886 Drug: ARRY-142886, MEK inhibitor; oral
Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

  Eligibility

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

Key Inclusion Criteria (Part 2):

  • Histopathologically or cytologically confirmed solid tumor that is refractory to standard therapies, or for which no standard therapies exist, or for which the Investigator feels no other active therapy is required for the duration of the study.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
  • Estimated life expectancy of greater than or equal to 3 months.
  • Patient must have a tumor that is accessible for biopsy and must consent to paired tumor biopsies and normal skin biopsies being taken pre- and post-dose of study drug.
  • Additional criteria exist.

Key Exclusion Criteria (Part 2):

  • Uncontrolled or symptomatic brain metastases.
  • Use of investigational drug or device within 30 days prior to first dose of study drug.
  • Major surgery within 30 days prior to study start.
  • Radiotherapy or chemotherapy within 21 days prior to study start (not including palliative radiotherapy at focal sites).
  • Pregnancy or lactation.
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
  • Additional criteria exist.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00085787     History of Changes
Other Study ID Numbers: ARRY-0401
Study First Received: June 14, 2004
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014