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A Study of ARRY-334543 in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00637702
First received: March 12, 2008
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Advanced Cancer
 Drug: ARRY-334543, EGFR/ErbB2 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Establish the maximum tolerated dose (MTD) of the new formulation of study drug. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Assess the exposure of the new formulation of study drug in terms of plasma concentrations. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the efficacy of the new formulation of study drug in terms of tumor dimension assessment. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: February 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-334543 Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
single dose and multiple dose, escalating

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637702

Locations
Canada, Ontario
Juravinski Cancer Center at Hamilton Heath Sciences
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00637702     History of Changes
Other Study ID Numbers: ARRAY-543-103
Study First Received: March 12, 2008
Last Updated: February 15, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 13, 2013