A Study of ARRY-142886 in Patients With Advanced Cancer | NCT00085787

Studies
A Study of ARRY-142886 in Patients With Advanced Cancer

NCT00085787

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Oct 14, 2020Actual

Enrollment

57Actual

Phase

Phase 1

Conditions

Advanced Cancer

Interventions

ARRY-142886, MEK inhibitor; oral

Countries

United States

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

Oct 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

Jun 2004

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Jun 14, 2004

First Submission Date that Met QC Criteria

Jun 16, 2004

First Posted Date

Jun 17, 2004Estimated

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

Oct 12, 2020

Last Update Posted Date

Oct 14, 2020Actual

Description Module

Brief Summary

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-142886.

This study has 2 parts. In the first part, patients 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 25 patients from the US will be enrolled in Part 1 (Completed).

In the second part of the study, patients 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 the study drug causes and what effectiveness the study drug has, if any, in treating the cancer. Approximately 35 patients from the US will be enrolled in Part 2 (Completed).

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

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARRY-142886	Experimental		Drug: ARRY-142886, MEK inhibitor; oral

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARRY-142886, MEK inhibitor; oral	Drug	Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule	ARRY-142886

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.		Part 1
Establish the maximum tolerated dose (MTD) of study drug.		Part 1
Assess the biological activity of the study drug in tumors in terms of inhibition of extracellular signal-regulated kinase (ERK) phosphorylation.		Part 2

Secondary Outcomes

Measure	Description	Time Frame
Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.		Part 1 and Part 2
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.		Part 1 and Part 2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria (Part 2):

Histopathologically or cytologically confirmed solid tumor that is refractory to standard therapies, or for which no standard therapies exist, or for which the Investigator feels no other active therapy is required for the duration of the study.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
Estimated life expectancy of greater than or equal to 3 months.
Patient must have a tumor that is accessible for biopsy and must consent to paired tumor biopsies and normal skin biopsies being taken pre- and post-dose of study drug.
Additional criteria exist.

Key Exclusion Criteria (Part 2):

Uncontrolled or symptomatic brain metastases.
Use of investigational drug or device within 30 days prior to first dose of study drug.
Major surgery within 30 days prior to study start.
Radiotherapy or chemotherapy within 21 days prior to study start (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.
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