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

Advanced Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710736
• Other study ID #: ARRAY-543-204
• Status: Completed
• Phase: Phase 1
• Start date: June 2008
• Est. completion date: April 2011

Study information

• Verified date: October 2020
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating
• Capecitabine, 5-fluorouracil prodrug; oral
multiple dose, single schedule

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency- Centre for the Southern Interior	Kelowna	British Columbia
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Array Biopharma, now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine.		Duration of study
Primary	Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.		Duration of study
Primary	Characterize the pharmacokinetics (PK) of study drug and capecitabine.		Duration of study
Secondary	Assess the efficacy of the study drug in combination with capecitabine in terms of tumor response and changes in serological tumor markers.		Duration of study
Secondary	Assess potential predictive biomarkers of clinical activity for the study drug in combination with capecitabine.		Duration of study