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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:
NCT00278902
First received: January 17, 2006
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  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: 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:
  • Establish the maximum tolerated dose (MTD) of study drug. [ Time Frame: Part 1 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: No ]
  • Assess the efficacy of the study drug in terms of tumor dimension assessment. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278902

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sarah Cannon Research Center
Nashville, Tennessee, United States, 37203
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

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00278902     History of Changes
Other Study ID Numbers: ARRY-0501
Study First Received: January 17, 2006
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013