A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer

This study has been completed.
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
First received: July 2, 2008
Last updated: September 28, 2012
Last verified: September 2012
This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US and Canada will be enrolled in this study.

Condition Intervention Phase
Advanced Cancer
Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
Drug: Capecitabine, 5-fluorouracil prodrug; 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:

Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics (PK) of study drug and capecitabine. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the efficacy of the study drug in combination with capecitabine in terms of tumor response and changes in serological tumor markers. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Assess potential predictive biomarkers of clinical activity for the study drug in combination with capecitabine. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: June 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-334543 + capecitabine Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating
Drug: Capecitabine, 5-fluorouracil prodrug; oral
multiple dose, single schedule


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

Key Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
  • Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
  • Must be able to take and retain oral medications.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Active concomitant malignancies.
  • 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).
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Requiring intravenous (IV) alimentation.
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
  • Pregnancy or lactation.
  • Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
  • Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
  • History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
  • Additional criteria exist.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710736

United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Canada, British Columbia
British Columbia Cancer Agency- Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Array BioPharma
  More Information

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00710736     History of Changes
Other Study ID Numbers: ARRAY-543-204 
Study First Received: July 2, 2008
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016