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Completed

NCT Number: NCT00637702

A Study of ARRY-334543 in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced solid tumors will receive a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug in order to achieve the highest dose possible that will not cause unacceptable side effects. The patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. In addition, the effect of food on the new formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this study (Active, not recruiting).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Juravinski Cancer Center at Hamilton Heath Sciences, Hamilton, Ontario, 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:

  • Histological or cytological evidence of malignancy.
  • Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
  • Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Uncontrolled brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
  • Use of an investigational medication or device within 30 days prior to first dose of study drug.
  • Major surgery within 30 days prior to first dose of study drug.
  • Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
  • Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
  • Pregnancy or lactation.
  • Known positive serology for the human immunodeficiency virus (HIV), 'active' hepatitis B and/or hepatitis C.
  • Additional criteria exist.

Treatment and study plan

ARRY-334543, EGFR/ErbB2 inhibitor; oral

Drug

single dose and multiple dose, escalating

Primary outcomes

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

    Time frame: Duration of study

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

    Time frame: Duration of study

  3. Characterize the pharmacokinetics (PK) of the new formulation of study drug (in terms of plasma concentrations) when administered in a fed versus fasted state.

    Time frame: Day 1 and Day 8

  4. Assess the exposure of the new formulation of study drug in terms of plasma concentrations.

    Time frame: Duration of study

Secondary outcomes

  1. Assess the efficacy of the new formulation of study drug in terms of tumor dimension assessment.

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 18, 2008
Registry last updated
Oct 8, 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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