A Study of ARRY-334543 in Patients With Advanced Cancer

NCT00278902 | Completed Phase 1

• 1 other identifier: ARRY-0501
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 5

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

Keywords

ErbB2+ Breast Cancer; HER2+ Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Establish the maximum tolerated dose (MTD) of study drug.

  Part 1

• 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 Outcomes (2)

• Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.

  Part 1 and Part 2

• Assess the efficacy of the study drug in terms of tumor dimension assessment.

  Part 1 and Part 2

Study Arms (1)

ARRY-334543

EXPERIMENTAL

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

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oral DRUG

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

ARRY-334543

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Array Biopharma, now a wholly owned subsidiary of Pfizer: lead

Study Sites (5)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Sarah Cannon Research Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

British Columbia Cancer Agency- Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Interventions

ARRY-334543

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: January 19, 2006
• Study Start: January 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

US (3); CA (2)