Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
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|ClinicalTrials.gov Identifier: NCT01579994|
Recruitment Status : Active, not recruiting
First Posted : April 18, 2012
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Lung Cancer||Drug: Ganetespib (STA-9090) and crizotinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers|
|Actual Study Start Date :||April 2012|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Ganetespib (STA-9090) and crizotinib
This protocol is a phase I single arm, open label, single institution study of crizotinib and ganetespib (STA-9090) in patients with ALK+ advanced NSCLC who are crizotinib naïve.
Drug: Ganetespib (STA-9090) and crizotinib
Ganetespib (STA-9090) is given intravenously (days 1 and 8 of a 21 day cycle). Crizotinib will be given at the FDA approved dose of 250mg orally twice daily in a continuous fashion.
- maximum tolerated dose [ Time Frame: 1 year ]A standard 3+3 design will be used to find the maximum tolerated dose (MTD). Patients who withdraw before completing a full cycle will be replaced. There will be three set dose levels, using the approved dose of crizotinib, with 50%, 75% and 100% of the ganetespib (STA-9090) maximum tolerated dose of 200 mg/m2.
- efficacy [ Time Frame: 1 year ]patients with ALK rearranged NSCLC at delaying acquired resistance to crizotinib by measuring progression free survival
- overall survival (OS) [ Time Frame: 1 year ]as defined by time from study entry to death due to any cause and overall response rate (RR), as defined by the combination of complete responses and partial responses according to RECIST 1.1
- safety profile [ Time Frame: 2 years ]Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579994
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memoral Sloan Kettering Cancer Center at Phelps|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Gregrory Riely, MD, PhD||Memorial Sloan Kettering Cancer Center|