Clinical trial NCT02271139: Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
Official title: An Open Label, Multicenter, Single-Arm, Expanded Access Study of Alectinib for Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an open-label, multicenter, single-arm, expanded access study designed to provide alectinib to participants with ALK-rearranged NSCLC after disease progression on or intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Participants will receive alectinib until disease progression, unacceptable toxicity, withdrawal of consent, patient or physician decision to discontinue treatment, death, alectinib becomes commercially available in the United States following approval of alectinib by the FDA, or the Sponsor decides to close the trial, whichever occurs first (approximately 15 months).


Eligibility criteria: Inclusion Criteria:

* Participants with locally advanced (American Joint Committee on Cancer \[AJCC\] Stage IIIB) not amenable to curative therapy or metastatic (AJCC Stage IV) NSCLC
* Life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-3
* Histologically confirmed NSCLC
* Documented ALK rearrangement as assessed by approved fluorescence in situ hybridization (FISH) test, using the Vysis ALK Break Apart FISH Probe Kit or the Ventana immunohistochemistry (IHC) test
* After disease progression on or intolerance to prior ALK TKI therapy: 1) participants need to have a minimum washout period of at least 5 half-lives between the last dose of ALK TKI therapy or other targeted therapies and the first dose of study treatment; 2) participants must have recovered from treatment toxicities to less than or equal to (\</=) Grade 1 or to their pretreatment levels (for participants who have developed interstitial lung disease \[ILD\], they must have fully recovered); 3) participants can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy for locally advanced or metastatic disease
* Recovery from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
* Adequate hematological and renal function
* Agreement to use highly effective methods of contraception per protocol definitions

Exclusion Criteria:

* Prior therapy with alectinib
* Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids within 1 week prior to Day 1 to manage CNS symptoms
* Administration of strong/potent cytochrome P450 3A (CYP3A) inhibitors or inducers, or agents with potential QT prolonging effects within 14 days prior to first administration of study drug
* Participants with liver disease
* Any clinically significant concomitant disease or condition that could interfere with the conduct of the study
* Active or uncontrolled infectious diseases requiring treatment
* History of organ transplant
* Participants with baseline QTc \> 470 milliseconds (ms) or participants with symptomatic bradycardia
* Pregnant or lactating, or intending to become pregnant during the study
* History of hypersensitivity to any of the additives in alectinib formulation
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participants before trial entry
* Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bimingham
country: United States
facility: University of Alabama
state: Alabama
city: Daphne
country: United States
facility: Southern Cancer Center
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center - Mobile
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Fountain Valley
country: United States
facility: Lalita Pandit Inc.
state: California
city: La Jolla
country: United States
facility: University of California San Diego Medical Center; Moores Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda Cancer Center
state: California
city: Los Angeles
country: United States
facility: LAC USC Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Sebastopol
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Med Center
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clin Rsch of IN
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Partners Can Ctr
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Med Ctr; Hem/Onc
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: Comprehensive Cancer Care, P.C.
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Cancer Center; Billings Cancer Research
state: Montana
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: New York
country: United States
facility: Columbia University Medical Center; Clinical Research Management Office
state: New York
city: Salisbury
country: United States
facility: W.G. Bill Hefner VA Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Mark H. Zangmeister Center
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Cancer Institute
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science Uni
state: Oregon
city: Monroeville
country: United States
facility: Forbes Hospital
state: Pennsylvania
city: Natrona Heights
country: United States
facility: Allegheny Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America - Eastern Regional Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Cancer Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina; Hollings Cancer Center
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Seattle
country: United States
facility: University of Washington Seattle Cancer Care Alliance
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Madison
country: United States
facility: University of Wisconsin; Oncology
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: