Completed

A Study of ARRY-142886 in Patients With Advanced Cancer

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ARRY-142886, MEK inhibitor; oral

Drug
Who is being recruted

Advanced Cancer

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2004

See protocol details

Summary

Principal SponsorArray Biopharma, now a wholly owned subsidiary of Pfizer
Last updated: October 14, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004Actual date on which the first participant was enrolled.

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).

Official TitleA Study of ARRY-142886 in Patients With Advanced Cancer 
Principal SponsorArray Biopharma, now a wholly owned subsidiary of Pfizer
Last updated: October 14, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
57 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Advanced Cancer
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
University of Colorado Cancer Center, Anschutz Cancer CenterAurora, United StatesSee the location
Suspended
Mayo Clinic RochesterRochester, United States
Suspended
Fox Chase Cancer CenterPhiladelphia, United States
Completed3 Study Centers