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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01579994
First received: April 16, 2012
Last updated: August 21, 2014
Last verified: August 2014

April 16, 2012
August 21, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
  • maximum tolerated dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    patients with ALK rearranged NSCLC at delaying acquired resistance to crizotinib by measuring progression free survival
  • maximum tolerated dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    patients with ALK rearranged NSCLC at delaying acquired resistance to crizotinib by measuring progression free survival
Complete list of historical versions of study NCT01579994 on ClinicalTrials.gov Archive Site
  • overall survival (OS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
Same as current
Not Provided
Not Provided
 
Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
A Phase I/II 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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Lung Cancer
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.
Experimental: Ganetespib (STA-9090) and crizotinib
This protocol is a phase I/II 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
April 2015
April 2015   (final data collection date for primary outcome measure)

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 or a creatinine clearance ≤ 60mL/min.

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.
Both
18 Years and older
No
Contact: Gregory Riely, MD PhD 646-888-4199
Contact: Paul Paik, MD 646-888-4202
United States
 
NCT01579994
12-015
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Gregrory Riely, MD, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

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