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A Study of ARRY-334543 in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT00637702
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : February 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Cancer Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2008
Primary Completion Date : October 2012
Study Completion Date : October 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: ARRY-334543 Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
single dose and multiple dose, escalating


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Assess the efficacy of the new formulation of study drug in terms of tumor dimension assessment. [ Time Frame: Duration of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00637702     History of Changes
Other Study ID Numbers: ARRAY-543-103
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Neoplasms