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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02271139
• Other study ID #: ML29453
• Status: No longer available
• Phase: N/A
• First received: October 17, 2014
• Last updated: March 7, 2017

Study information

• Verified date: March 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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).

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Disease Progression
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Alectinib
Alectinib 600 mg administered orally with food.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States,