A Study of ARRY-380 in Patients With Advanced HER2+ Cancer | NCT00650572

Studies
A Study of ARRY-380 in Patients With Advanced HER2+ Cancer

NCT00650572

Sponsor

Seagen Inc.

Status

Completed

Last Update Posted

May 7, 2020Actual

Enrollment

50Actual

Phase

Phase 1

Conditions

Cancer

Interventions

ARRY-380, HER2 inhibitor; oral

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Mar 31, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2020

Last Update Posted Date

May 7, 2020Actual

Name	Class
Array BioPharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380.

This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies, who have already received at least one previous standard therapy, will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Completed).

In the second part of this study, patients with HER2+ metastatic breast cancer, who have already received at least one previous standard therapy, will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 20 patients from the US will be enrolled in Part 2 (Active, not recruiting).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
ARRY-380	Experimental		Drug: ARRY-380, HER2 inhibitor; oral

Name	Type	Description	Arm Group Labels	Other Names
ARRY-380, HER2 inhibitor; oral	Drug	Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.	ARRY-380

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.		Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.		Part 1, one year
Characterize the pharmacokinetics of the study drug.		Part 2, one year
Assess amplification/expression of HER2 in archival and tumor tissues.		Part 2, one year

Secondary Outcomes

Measure	Description	Time Frame
Characterize the pharmacokinetics of the study drug.		Part 1, one year
Assess changes in tumor markers.		Part 1, one year
Assess the efficacy of study drug in terms of tumor response and duration of response.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria (Part 1 and Part 2):

Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2).
Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy (patients with HER2+ breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib, if available).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

Uncontrolled or symptomatic brain metastases (patients may be considered adequately controlled if on a stable steroid dose for at least 30 days).
Treatment with an investigational medicinal product or device within 30 days prior to first dose of study drug.
Radiotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
Chemotherapy within 21 days prior to first dose of study drug.
Major surgery within 30 days prior to first dose of study drug.
Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
Additional criteria exist.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
The University of Colorado Cancer Center		Aurora	Colorado		United States
The University of Texas, MD Anderson Cancer Center