A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT01871805
Last Updated: 2018-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
134 participants
INTERVENTIONAL
2013-09-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alectinib: Phase I (Dose Escalation)
Participants will receive escalating doses of alectinib capsules orally until disease progression, death or withdrawal for any other reasons.
Alectinib
Participants will receive alectinib as described in the arm descriptions.
Alectinib (Phase II: RP2 dose)
Participants will receive recommended Phase II dose as determined from Phase I until disease progression, death or withdrawal for any other reasons.
Alectinib
Participants will receive alectinib as described in the arm descriptions.
Interventions
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Alectinib
Participants will receive alectinib as described in the arm descriptions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test
* NSCLC that has failed crizotinib treatment
* Measurable disease as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
* Adequate hematologic, hepatic and renal function
Exclusion Criteria
* Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment
* History of serious cardiac dysfunction
* History of or current active infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* Clinically significant gastrointestinal abnormality that would affect absorption of the drug
* Pregnant or lactating women
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California Irvine
Irvine, California, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Loma Linda Cancer Center
Loma Linda, California, United States
UCLA
Los Angeles, California, United States
Univ of Colorado Canc Ctr
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Lynn Regional Cancer Center West
Boca Raton, Florida, United States
Florida Hospital Cancer Inst
Orlando, Florida, United States
UF Health Orlando
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Monroe Medical Associates; Ingalls Memorial Hosp
Harvey, Illinois, United States
Massachussets General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Can Ins
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
St. Joseph Mercy Hospital; Cancer Care Center.
Ann Arbor, Michigan, United States
Wayne State Uni ; Karmanos Cancer Center
Detroit, Michigan, United States
Hackensack Univ Med Ctr
Hackensack, New Jersey, United States
Roswell Park Cancer Inst.
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States
Richmond University Medical Center; Pharmacy Department
Staten Island, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Providence Portland Med Ctr
Portland, Oregon, United States
Oregon Health & Science Uni
Portland, Oregon, United States
St. Luke's Hospital; Pharmacy Department
Bethlehem, Pennsylvania, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Pavillion
Pittsburgh, Pennsylvania, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
Center for Biomedical Research LLC
Knoxville, Tennessee, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Swedish Cancer Inst.
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada
Countries
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References
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Gadgeel S, Shaw AT, Barlesi F, Crino L, Yang JC, Dingemans AM, Kim DW, de Marinis F, Schulz M, Liu S, Gupta R, Smoljanovic V, Ou SI. Time To Response In Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small-Cell Lung Cancer (NSCLC) Receiving Alectinib In The Phase II NP28673 And NP28761 Studies. Lung Cancer (Auckl). 2019 Nov 13;10:125-130. doi: 10.2147/LCTT.S209231. eCollection 2019.
Ou SI, Gadgeel SM, Barlesi F, Yang JC, De Petris L, Kim DW, Govindan R, Dingemans AM, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Mitry E, Muller B, Bordogna W, Balas B, Morcos PN, Shaw AT. Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer. Lung Cancer. 2020 Jan;139:22-27. doi: 10.1016/j.lungcan.2019.10.015. Epub 2019 Oct 14.
Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.
Gadgeel SM, Shaw AT, Govindan R, Gandhi L, Socinski MA, Camidge DR, De Petris L, Kim DW, Chiappori A, Moro-Sibilot DL, Duruisseaux M, Crino L, De Pas T, Dansin E, Tessmer A, Yang JC, Han JY, Bordogna W, Golding S, Zeaiter A, Ou SI. Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Dec;34(34):4079-4085. doi: 10.1200/JCO.2016.68.4639. Epub 2016 Oct 31.
Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.
Shaw AT, Gandhi L, Gadgeel S, Riely GJ, Cetnar J, West H, Camidge DR, Socinski MA, Chiappori A, Mekhail T, Chao BH, Borghaei H, Gold KA, Zeaiter A, Bordogna W, Balas B, Puig O, Henschel V, Ou SI; study investigators. Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial. Lancet Oncol. 2016 Feb;17(2):234-242. doi: 10.1016/S1470-2045(15)00488-X. Epub 2015 Dec 19.
Gadgeel SM, Gandhi L, Riely GJ, Chiappori AA, West HL, Azada MC, Morcos PN, Lee RM, Garcia L, Yu L, Boisserie F, Di Laurenzio L, Golding S, Sato J, Yokoyama S, Tanaka T, Ou SH. Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol. 2014 Sep;15(10):1119-28. doi: 10.1016/S1470-2045(14)70362-6. Epub 2014 Aug 18.
Other Identifiers
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NP28761
Identifier Type: -
Identifier Source: org_study_id
NCT01588028
Identifier Type: -
Identifier Source: nct_alias
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