Lung Cancer Clinical Trial

A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib

Summary

The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.

View Full Description

Full Description

This is a 3-part phase 1-2 study in patients with anaplastic lymphoma kinase (ALK) + or other potentially crizotinib-sensitive NSCLC who have been receiving crizotinib. Part A is a single-arm, Phase 1, open-label, dose escalation design in patients with NSCLC who have already been receiving crizotinib for at least 8 weeks and continue to tolerate therapy. Part B is a Phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + AT13387 at the maximum tolerated dose established in Part A. Part C is an open-label, randomized, Phase 2, Simon's 2 stage design evaluating single agent AT13387 or combination AT13387 + crizotinib at the MTD established in Part A in patients who progressed on crizotinib at any time.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Men or women 18 years of age or older
Must have Non-small Cell Lung Cancer with ALK+ mutation or other mutations or rearrangements potentially sensitive to crizotinib
Measurable disease
Must have been receiving or have received crizotinib
Have adequate cardiac, bone marrow, liver and kidney function
Must be willing and able to provide written informed consent and comply with the protocol and study procedures

Exclusion Criteria:

Prior anti-cancer treatment with any HSP90 inhibitor
Have received chemotherapy, radiation therapy or other anticancer treatment other than crizotinib within 3 weeks prior to the first dose of study drug
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
Abnormal heart function
Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors
Hypersensitivity of AT13387 or other components of the drug product
Treatment with an investigational drug within 3 weeks prior to the first dose of study drug
Severe systemic diseases or active uncontrolled infections
Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT01712217

Recruitment Status:

Completed

Sponsor:

Astex Pharmaceuticals, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 65 Locations for this study

See Locations Near You

Mayo Clinic-Scottsdale
Scottsdale Arizona, 85259, United States
University of California, San Diego Medical Center
La Jolla California, 92093, United States
USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
UCLA Medical Center
Los Angeles California, 90095, United States
Sharp Clinical Oncology Research-Sharp Memorial Hospital
San Diego California, 92123, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
University of Colorado Denver
Aurora Colorado, 80045, United States
Yale University School of Medicine-Yale Cancer Center
New Haven Connecticut, 06519, United States
Christiana Hospital
Newark Delaware, 19713, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Northwestern University The Feinberg School of Medicine
Chicago Illinois, 60611, United States
University of Chicago
Chicago Illinois, 60637, United States
Indiana University Melvin and and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
University of Michigan Medical Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic-Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center Eppley Cancer Center
Omaha Nebraska, 68198, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Columbia University Medical Center
New York New York, 10032, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cone Health Cancer Center
Greensboro North Carolina, 27409, United States
Oncology Hematology in Cincinnati
Cincinnati Ohio, 45242, United States
University of Cincinnati Cancer Institute
Cincinnati Ohio, 45267, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
The Pennsylvania State University-Penn State
Hershey Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
The West Clinic
Germantown Tennessee, 38138, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
University of Washington Medical Center
Seattle Washington, 98109, United States
University of Wisconsin-Carbone Cancer Center
Madison Wisconsin, 53579, United States
Atlantic Clinical Cancer Research Unit
Halifax Nova Scotia, B3H 1, Canada
McGill University Health Center
Montreal, Quebec , H3A 1, Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Sainte-Foy, Quebec , G1V 4, Canada
Princess Margaret Hospital
Toronto, Ontario , M5G 2, Canada
Cancer Care Manitoba
Winnipeg , R3E O, Canada
Centre Hospitalier Regional Universitaire Besancon
Besancon Cedex , 25030, France
CHU de Caen-Hopital Cote de Nacre
Caen , 14033, France
Hopital Saint Antoine
Creteil Cedex , 94010, France
Centre Hospitalier de Grenoble
Grenoble , 38043, France
CHRU de Lille
Lille cedex , 59037, France
Institut Paoli-Calmettes
Marseille , 13273, France
Hopital Tenon
Paris , 75020, France
Centre Hospitalier Lyon Sud
Pierre-Benite Cedex , 69495, France
CHU Toulouse-Hopital Larrey
Toulouse , 31 05, France
Institut Gustave Roussy
Villejuif , 94800, France
Chungbuk National University Hospital
Cheongju-si , 362-7, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
Gyeonggi-do , 442-7, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun-gun Jeonnam , 519-8, Korea, Republic of
National Cancer Center
Korea , 410-7, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam , 463-7, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 120-7, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Asan Medical Center
Seoul , 138-7, Korea, Republic of
Hospital Germans Trias i Pujol
Badalona , 08916, Spain
Hospital Universitari Quiron Dexeus Barcelona
Barcelona , 08028, Spain
Centro Integral Oncologico Clara Campal
Madrid , 28050, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT01712217

Recruitment Status:

Completed

Sponsor:


Astex Pharmaceuticals, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider