A Study of ARRY-334543 in Patients With Advanced Cancer

NCT ID: NCT00278902

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-06-30

Brief Summary

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).

In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).

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

Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oral

Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the Sponsor.
• Measurable disease (at least 1 target lesion) according to modified RECIST.
• Failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Must consent to allow the Sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy.
• Additional criteria exist.

Exclusion Criteria

• 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).
• 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).
• Pregnancy or lactation.
• Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they may be enrolled even if they are positive for 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

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Center

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

British Columbia Cancer Agency- Centre for the Southern Interior

Kelowna, British Columbia, Canada

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Countries

United States; Canada

Other Identifiers

ARRY-0501

Identifier Type: -

Identifier Source: org_study_id