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A Study of ARRY-334543 in Patients With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278902
First Posted: January 19, 2006
Last Update Posted: October 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Array BioPharma
  Purpose

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).

In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).


Condition Intervention Phase
Advanced Cancer Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Establish the maximum tolerated dose (MTD) of study drug. [ Time Frame: Part 1 ]
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: Part 1 and Part 2 ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations. [ Time Frame: Part 1 and Part 2 ]
  • Assess the efficacy of the study drug in terms of tumor dimension assessment. [ Time Frame: Part 1 and Part 2 ]

Enrollment: 96
Study Start Date: January 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-334543 Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria (Part 2):

  • Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the Sponsor.
  • Measurable disease (at least 1 target lesion) according to modified RECIST.
  • Failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Must consent to allow the Sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy.
  • Additional criteria exist.

Key Exclusion Criteria (Part 2):

  • Uncontrolled or symptomatic 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).
  • Pregnancy or lactation.
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they may be enrolled even if they are positive for 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): NCT00278902


Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Sarah Cannon Research Center
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Canada, British Columbia
British Columbia Cancer Agency- Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
Array BioPharma
  More Information

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00278902     History of Changes
Other Study ID Numbers: ARRY-0501
First Submitted: January 17, 2006
First Posted: January 19, 2006
Last Update Posted: October 1, 2012
Last Verified: September 2012

Keywords provided by Array BioPharma:
ErbB2+ Breast Cancer
HER2+ Breast Cancer

Additional relevant MeSH terms:
Neoplasms