A Study of ARRY-334543 in Patients With Advanced Cancer

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00278902

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

19.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: ARRY-334543

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
2	Sarah Cannon Research Center	Nashville	Tennessee	United States	37203
3	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
4	British Columbia Cancer Agency- Centre for the Southern Interior	Kelowna	British Columbia	Canada	V1Y 5L3
5	British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6

Sponsors and Collaborators

Array Biopharma, now a wholly owned subsidiary of Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Array Biopharma, now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00278902

Other Study ID Numbers:

ARRY-0501

First Posted:

Jan 19, 2006

Last Update Posted:

Oct 14, 2020

Last Verified:

Oct 1, 2020

Keywords provided by Array Biopharma, now a wholly owned subsidiary of Pfizer

ErbB2+ Breast Cancer

HER2+ Breast Cancer

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Oct 14, 2020