A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib
NCT ID: NCT01712217
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2012-10-31
2017-05-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone
NCT01513174
Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
NCT01101334
A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)
NCT02013219
A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer
NCT06417008
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
NCT03052608
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AT13387 and Crizotinib
Part A is a single-arm, Phase 1, open-label, dose-escalation design in patients with NSCLC who have already been receiving crizotinib 250 mg by mouth (PO) twice daily (BID) for at least 8 weeks and are still tolerating treatment at that dose. Patients will continue treatment with crizotinib + escalating doses of AT13387 IV weekly for 3 weeks in a 4-week cycle. Each cohort will consist of at least 6 patients until the maximum tolerated dose (MTD) is reached. An additional 12 patients will be treated at the MTD level of AT13387 in combination with crizotinib to confirm the safety profile of the combination at that dose level.
AT13387
HSP90 inhibitor
Crizotinib
ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene1, receptor tyrosine kinase) inhibitor
Crizotinib versus crizotinib + AT13387
Part B is a Phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + AT13387 at the MTD established in Part A. Part B will enroll 128 patients with NSCLC who have been treated with crizotinib for at least 8 weeks and are still tolerating treatment without evidence of disease progression.
AT13387
HSP90 inhibitor
Crizotinib
ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene1, receptor tyrosine kinase) inhibitor
AT13387 or AT13387 + crizotinib
Part C is an open-label, randomized, Phase 2, Simon's 2-stage design of AT13387 administered alone once weekly for 3 weeks (QW×3) or in combination with crizotinib at the MTD established in Part A.
AT13387
HSP90 inhibitor
Crizotinib
ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene1, receptor tyrosine kinase) inhibitor
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AT13387
HSP90 inhibitor
Crizotinib
ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene1, receptor tyrosine kinase) inhibitor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Must have Non-small Cell Lung Cancer with ALK+ mutation or other mutations or rearrangements potentially sensitive to crizotinib
3. Measurable disease
4. Must have been receiving or have received crizotinib
5. Have adequate cardiac, bone marrow, liver and kidney function
6. Must be willing and able to provide written informed consent and comply with the protocol and study procedures
Exclusion Criteria
2. Have received chemotherapy, radiation therapy or other anticancer treatment other than crizotinib within 3 weeks prior to the first dose of study drug
3. Prior malignancy other than adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, low-grade cervical cancer, non-metastatic prostate cancer, or have been disease-free for at least 3 years
4. Abnormal heart function
5. Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors
6. Hypersensitivity of AT13387 or other components of the drug product
7. Treatment with an investigational drug within 3 weeks prior to the first dose of study drug
8. Severe systemic diseases or active uncontrolled infections
9. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astex Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic-Scottsdale
Scottsdale, Arizona, United States
University of California, San Diego Medical Center
La Jolla, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Sharp Clinical Oncology Research-Sharp Memorial Hospital
San Diego, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale University School of Medicine-Yale Cancer Center
New Haven, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University Melvin and and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic-Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center Eppley Cancer Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Oncology Hematology in Cincinnati
Cincinnati, Ohio, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
The Pennsylvania State University-Penn State
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The West Clinic
Germantown, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin-Carbone Cancer Center
Madison, Wisconsin, United States
Atlantic Clinical Cancer Research Unit
Halifax, Nova Scotia, Canada
McGill University Health Center
Montreal, Quebec, , Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Sainte-Foy, Quebec, , Canada
Princess Margaret Hospital
Toronto, Ontario, , Canada
Cancer Care Manitoba
Winnipeg, , Canada
Centre Hospitalier Regional Universitaire Besancon
Besançon, , France
CHU de Caen-Hopital Cote de Nacre
Caen, , France
Hopital Saint Antoine
Créteil, , France
Centre Hospitalier de Grenoble
Grenoble, , France
CHRU de Lille
Lille, , France
Institut Paoli-Calmettes
Marseille, , France
Hopital Tenon
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Toulouse-Hopital Larrey
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Chungbuk National University Hospital
Cheongju-si, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Gyeonggi-do, , South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun Jeonnam, , South Korea
National Cancer Center
Korea, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-001575-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AT13387-05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.