Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
NCT ID: NCT01579994
Last Updated: 2020-12-30
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
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2012-04-16
2020-12-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Positive for translocation or inversion events involving the ALK gene locus as determined standard methods (including but not limited to by FISH and IHC testing).
* No prior treatment with crizotinib, but they may have received prior cytotoxic chemotherapy.
* Age ≥ 18 years.
* Measurable (RECIST 1.1) indicator lesion not previously irradiated.
* Karnofsky Performance Status ≥ 70%
* Able to take oral medications
* A negative serum pregnancy test obtained within two weeks prior to administration of the experimental agents in all pre-menopausal women (last menstrual period ≤ 24 months ago).
* All women of child bearing potential (WOCBP) and sexually active men must agree to use adequate methods of birth control throughout the study which include use of oral contraceptives with an additional barrier method, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy and/or tubal libation and total abstinence.
Exclusion Criteria
* Inadequate recovery from any toxicity related to prior treatment (to Grade 1 or baseline).
* Inadequate hematologic function defined as:
* Absolute neutrophil count (ANC) \< 1,000 cells/mm³.
* Platelet count \< 75,000/mm³
* Hemoglobin \< 9.0g/dL.
Inadequate hepatic function defined by:
* AST and/or ALT \> 3x upper limited of normal (ULN).
* Total bilirubin \> 2x ULN.
* Alkaline phosphatase \> 3x ULN.
* Patients with hepatic metastases may have ALT/AST ≤ 5x ULN.
* Patients with hepatic and/or bone metastases may have an AP ≤ 5x ULN.
* Inadequate renal function defined by serum creatinine \> 2x ULN Uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs/symptoms related to infection without improvement, despite appropriate anti-infective medications or other treatment).
* Patients with clinically active brain metastasis (requiring therapy with steroids or radiation therapy). Patients with clinically stable brain metastases (previously treated or untreated) for two weeks are eligible.
* Significant cardiac disease (e.g. New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias).
* Previously or current malignancies at other sites within the last 2 years, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, or prostate cancer that does not require active treatment per National Comprehensive Cancer Network (NCCN) guidelines.
* Women who are pregnant or lactating
* Use of drugs or food that are known potent CYP3A4 inhibitors (see Appendix C)
* Use of drugs that are known potent CYP3A4 inducers (see Appendix D)
* Any other condition that, in the opinion of the Investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gregrory Riely, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
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
Countries
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References
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Wong KM, Noonan S, O'Bryant C, Jimeno A. Alectinib for the treatment of ALK-positive stage IV non-small cell lung cancer. Drugs Today (Barc). 2015 Mar;51(3):161-70. doi: 10.1358/dot.2015.51.3.2294597.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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12-015
Identifier Type: -
Identifier Source: org_study_id