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.
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.
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
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There are 65 Locations for this study
Scottsdale Arizona, 85259, United States
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
San Diego California, 92123, United States
Whittier California, 90603, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06519, United States
Newark Delaware, 19713, United States
Orlando Florida, 32804, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Lebanon New Hampshire, 03756, United States
Bronx New York, 10461, United States
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Greensboro North Carolina, 27409, United States
Cincinnati Ohio, 45242, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97213, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19107, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Madison Wisconsin, 53579, United States
Halifax Nova Scotia, B3H 1, Canada
Montreal, Quebec , H3A 1, Canada
Sainte-Foy, Quebec , G1V 4, Canada
Toronto, Ontario , M5G 2, Canada
Winnipeg , R3E O, Canada
Besancon Cedex , 25030, France
Caen , 14033, France
Creteil Cedex , 94010, France
Grenoble , 38043, France
Lille cedex , 59037, France
Marseille , 13273, France
Paris , 75020, France
Pierre-Benite Cedex , 69495, France
Toulouse , 31 05, France
Villejuif , 94800, France
Cheongju-si , 362-7, Korea, Republic of
Gyeonggi-do , 442-7, Korea, Republic of
Hwasun-gun Jeonnam , 519-8, Korea, Republic of
Korea , 410-7, Korea, Republic of
Seongnam , 463-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Badalona , 08916, Spain
Barcelona , 08028, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
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