A Study of ARRY-334543 in Patients With Advanced Cancer

Array BioPharma

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637702

ARRAY-543-103

Details and patient eligibility

About

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).

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

ARRY-334543

Experimental group

Treatment:

Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral