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Completed

NCT Number: NCT00462358

A Study of ARRY-520 in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-520.

This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 15 patients (per schedule) 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 evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15 patients from the US will be enrolled in Part 2 (Completed).

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Marlene and Stewart Greenebaum Cancer Center, Baltimore, Maryland, 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:

  • Histological or cytological evidence of malignancy.
  • Advanced solid tumors that have recurred or progressed following standard therapy(ies).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Adequate hematology counts and serum chemistry values.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Treatment with an investigational product or device, or anti-neoplastic therapy (with the exclusion of hormone therapy where the therapy will continue at a standard dose throughout the study) within 28 days prior to the first dose of study drug.
  • Major surgery within 28 days prior to the first dose of study drug.
  • Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if local RT to <5% of the bone marrow).
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
  • Additional criteria exist.

Treatment and study plan

ARRY-520, KSP(Eg5) inhibitor; intravenous

Drug

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

Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

Drug

Part 1: standard of care; Part 2: standard of care.

Primary outcomes

  1. Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.

    Time frame: Part 1

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

    Time frame: Part 1 and Part 2

Secondary outcomes

  1. Characterize the pharmacokinetics of the study drug.

    Time frame: Part 1 and Part 2

  2. Assess the efficacy of the study drug in terms of tumor response.

    Time frame: Part 1 and Part 2

Sponsors and collaborators

Lead sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 19, 2007
Registry last updated
Sep 28, 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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