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

Advanced Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833326
• Other study ID #: ARRAY-543-104
• Status: Completed
• Phase: Phase 1
• Start date: January 2009
• Est. completion date: July 2010

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 docetaxel (with prophylactic growth factor support). Patients will receive increasing doses of study drug in combination with docetaxel 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 will be enrolled in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• 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 solid tumor suitable for treatment with docetaxel.

• Tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.

• Must be able to take and retain oral medications.

• Other 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 prior to study start).

• Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.

• Requiring intravenous (IV) alimentation.

• Pregnancy or lactation.

• Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.

• Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug.

• History of hypersensitivity to or intolerance of docetaxel.

• Other criteria exist.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating
• Docetaxel, mitotic inhibitor; intravenous
multiple dose, single schedule
• Prophylactic growth factors; subcutaneous
standard of care

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Mayo Cancer Center	Rochester	Minnesota

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

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