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NCT Number: NCT00650572

A Study of ARRY-380 in Patients With Advanced HER2+ Cancer

This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380.

This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies, who have already received at least one previous standard therapy, 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 30 patients from the US will be enrolled in Part 1 (Completed).

In the second part of this study, patients with HER2+ metastatic breast cancer, who have already received at least one previous standard therapy, 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 and effectiveness the study drug has, if any, in treating the cancer. Approximately 20 patients from the US will be enrolled in Part 2 (Active, not recruiting).

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria (Part 1 and Part 2):

  • Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2).
  • Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy (patients with HER2+ breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib, if available).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
  • Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

  • Uncontrolled or symptomatic brain metastases (patients may be considered adequately controlled if on a stable steroid dose for at least 30 days).
  • Treatment with an investigational medicinal product or device within 30 days prior to first dose of study drug.
  • Radiotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
  • Chemotherapy within 21 days prior to first dose of study drug.
  • Major surgery within 30 days prior to first dose of study drug.
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
  • Additional criteria exist.

Treatment and study plan

ARRY-380, HER2 inhibitor; oral

Drug

Part 1: 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 and electrocardiograms.

    Time frame: Part 1, one year; Part 2, one year

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

    Time frame: Part 1, one year

  3. Characterize the pharmacokinetics of the study drug.

    Time frame: Part 2, one year

  4. Assess amplification/expression of HER2 in archival and tumor tissues.

    Time frame: Part 2, one year

Secondary outcomes

  1. Characterize the pharmacokinetics of the study drug.

    Time frame: Part 1, one year

  2. Assess changes in tumor markers.

    Time frame: Part 1, one year

  3. Assess the efficacy of study drug in terms of tumor response and duration of response.

    Time frame: Part 1, one year; Part 2, one year

  4. Assess expression of growth factor pathway proteins in archival and tumor tissues.

    Time frame: Part 2, one year

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Array BioPharma

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2008
Registry last updated
May 7, 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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