- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01579994
Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
December 28, 2020 updated by: Memorial Sloan Kettering Cancer Center
A Phase I Study of Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
About 18 patients will take part in the phase 1 portion of the trial.
In the beginning of the study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard dose of crizotinib.
If this dose does not cause significant side effects, it will be increased as new patients take part in the study.
The study will only be open at Memorial Sloan Kettering Cancer Center.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States
- Memoral Sloan Kettering Cancer Center
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, United States
- Memorial Sloan Kettering at Mercy Medical Center
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Sleepy Hollow, New York, United States, 10591
- Memoral Sloan Kettering Cancer Center at Phelps
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically proven diagnosis confirmed at MSKCC of advanced lung adenocarcinoma that is locally advanced or metastatic (stage III/IV).
- 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:
- Prior crizotinib therapy
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximum tolerated dose
Time Frame: 1 year
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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.
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1 year
|
efficacy
Time Frame: 1 year
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patients with ALK rearranged NSCLC at delaying acquired resistance to crizotinib by measuring progression free survival
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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1 year
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safety profile
Time Frame: 2 years
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Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
|
2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gregrory Riely, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2012
Primary Completion (Actual)
December 28, 2020
Study Completion (Actual)
December 28, 2020
Study Registration Dates
First Submitted
April 16, 2012
First Submitted That Met QC Criteria
April 17, 2012
First Posted (Estimate)
April 18, 2012
Study Record Updates
Last Update Posted (Actual)
December 30, 2020
Last Update Submitted That Met QC Criteria
December 28, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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