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NCT Number: NCT00085787

A Study of ARRY-142886 in Patients With Advanced Cancer

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).

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Cancer Center, Anschutz Cancer Center, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARRY-142886, MEK inhibitor; oral

Drug

Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

Primary outcomes

  1. Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.

    Time frame: Part 1

  2. Establish the maximum tolerated dose (MTD) of study drug.

    Time frame: Part 1

  3. 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

Secondary outcomes

  1. Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.

    Time frame: Part 1 and Part 2

  2. Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.

    Time frame: Part 1 and Part 2

  3. Assess the efficacy of the study drug in terms of tumor dimension assessment.

    Time frame: Part 1 and Part 2

  4. 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

Sponsors and collaborators

Lead sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 17, 2004
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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