A Study of ARRY-334543 in Patients With Advanced Cancer

NCT ID: NCT00637702

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-10-31

Brief 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).

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARRY-334543

Group Type: EXPERIMENTAL

ARRY-334543, EGFR/ErbB2 inhibitor; oral

Intervention Type: DRUG

single dose and multiple dose, escalating

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oral

single dose and multiple dose, escalating

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Juravinski Cancer Center at Hamilton Heath Sciences

Hamilton, Ontario, Canada

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

ARRAY-543-103

Identifier Type: -

Identifier Source: org_study_id