A Study of ARRY-334543 in Patients With Advanced Cancer

Advanced Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637702
• Other study ID #: ARRAY-543-103
• Status: Completed
• Phase: Phase 1
• Start date: February 2008
• Est. completion date: October 2012

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 solid tumors will receive a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug in order to achieve the highest dose possible that will not cause unacceptable side effects. The patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. In addition, the effect of food on the new formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this study (Active, not recruiting).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Histological or cytological evidence of malignancy.

• Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.

• Cardiac ejection fraction = 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA).

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

• Additional criteria exist.

Key Exclusion Criteria:

• Uncontrolled 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).

• Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.

• Pregnancy or lactation.

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

• Additional criteria exist.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• ARRY-334543, EGFR/ErbB2 inhibitor; oral
single dose and multiple dose, escalating

Locations

Country	Name	City	State
Canada	Juravinski Cancer Center at Hamilton Heath Sciences	Hamilton	Ontario
Canada	Ottawa Hospital Cancer Centre	Ottawa	Ontario

Sponsors (1)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the safety profile of the new formulation of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.		Duration of study
Primary	Establish the maximum tolerated dose (MTD) of the new formulation of study drug.		Duration of study
Primary	Characterize the pharmacokinetics (PK) of the new formulation of study drug (in terms of plasma concentrations) when administered in a fed versus fasted state.		Day 1 and Day 8
Primary	Assess the exposure of the new formulation of study drug in terms of plasma concentrations.		Duration of study
Secondary	Assess the efficacy of the new formulation of study drug in terms of tumor dimension assessment.		Duration of study