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Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01579994
Recruitment Status : Active, not recruiting
First Posted : April 18, 2012
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE April 16, 2012
First Posted Date  ICMJE April 18, 2012
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE April 2012
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2012)
  • 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 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
Official Title  ICMJE A Phase I Study of Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Lung Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Ganetespib (STA-9090) and crizotinib
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2012)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01579994
Other Study ID Numbers  ICMJE 12-015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregrory Riely, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP