A Study of ARRY-334543 in Patients With Advanced Cancer

Advanced Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278902
• Other study ID #: ARRY-0501
• Status: Completed
• Phase: Phase 1
• Start date: January 2006
• Est. completion date: June 2009

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria (Part 2):

• 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.

Key Exclusion Criteria (Part 2):

• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• ARRY-334543, EGFR/ErbB2 inhibitor; oral
Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency- Centre for the Southern Interior	Kelowna	British Columbia
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
United States	Sarah Cannon Research Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the maximum tolerated dose (MTD) of study drug.		Part 1
Primary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.		Part 1 and Part 2
Secondary	Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.		Part 1 and Part 2
Secondary	Assess the efficacy of the study drug in terms of tumor dimension assessment.		Part 1 and Part 2