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SPC 1512   |   12-330
A Single Arm, Phase 2 Study of Ganetespib in Subjects with Advanced Non Small-Cell Lung Cancer with Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)

Main Campus
Phase 2

Contact Information
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  1. Primary
    • Determine the objective response rate (ORR) of ganetespib in subjects with advanced ALK-positive NSCLC
  2. Secondary
    • Determine the overall progression-free survival (PFS), 6 month PFS and 1 year PFS.
    • Determine duration of response
    • Determine the overall survival (OS) and 1 year survival.
    • Determine the disease control rate (DCR) at weeks 6 and 12.
    • Determine the change in tumor size (CTS) at weeks 6 and 12.
    • Evaluate the qualitative and quantitative toxicities associated with ganetespib in subjects with ALK positive NSCLC.
    • Evaluate symptom improvement using Functional Assessment of Cancer Therapy Lung (FACT-L) version 4.
    • Determine the relationship of clinical outcome with relevant biomarkers and genetic changes present in tumor tissues and serum samples.

Inclusion Criteria
A subject is eligible for the study if all of the following criteria are met:
  1. Males and females aged 18 years or older
  2. Pathological confirmation (by histology or cytology) of advanced NSCLC a) De novo disease (i.e., 0 lines of prior therapy; stage IIIB or IV NSCLC according to the AJCC Cancer Staging Manual 7th Edition 2010) (see protocol appendix II)) OR b) Recurrent disease with up to 3 lines of prior systemic therapy (i.e., 1-3)
  3. Histological confirmation of adenocarcinoma (see protocol appendix I)
  4. Evidence of a translocation or an inversion event involving the ALK gene locus as determined by either a local or central laboratory, or prior documentation of ALK-positive status by a local laboratory
  5. Availability of recent tumor tissue or a minimum of 10 slides of archived tumor tissue is required for ALK rearrangement confirmation testing and evaluating relevant biomarkers
  6. ECOG Performance Status 0 or 1 (see protocol appendix III)
  7. Adequate hematologic function defined as:
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    • Hemoglobin ≥ 9 g/dL
    • Platelets ≥ 100 x 10^9/L
  8. Adequate hepatic function defined as:
    • Albumin ≥ 3 g/dL
    • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 x ULN without liver metastases; ≤ 5 x ULN if documented liver metastases
  9. Adequate renal function defined as
    • Serum creatinine ≤ 1.2 mg/dL or calculated creatinine clearance (CLcr) per Cockcroft-Gault formula ≥ 50 mL/min
  10. Negative serum pregnancy test at study entry for female subjects of childbearing potential: a woman is considered to be of child bearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oopherectomy, or is postmenopausal (without a menstrual period for at least one year)
  11. Ability to understand, and willingness to sign, a written informed consent document and comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria
A subject is excluded from the study if any of the following criteria are met:
  1. Prior therapy with crizotinib
  2. Prior therapy with other ALK-targeted agents
  3. Prior treatment with any Hsp90 inhibitor
  4. Known EGFR activating mutation
  5. Presence of active or untreated central nervous system (CNS) metastases as determined by magnetic resonance imaging (MRI) or computed technology (CT) scan performed during screening or individuals who have been treated for CNS metastasis and discontinued the steroid treatment less than 4 weeks prior to Cycle 1 Day 1
  6. Active malignancies other than NSCLC within the previous 2 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
  7. Known serious cardiac illness including but not confined to:
    • Uncontrolled congestive heart failure (CHF), New York Heart Association class II/III/IV (see protocol appendix IV), with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics. NOTE: Use of these medications for the treatment of hypertension is allowed
    • Baseline QTc > 470 msec or history of QT prolongation while taking other medications
    • Left ventricular ejection fraction (LVEF) < 45%
    • High-risk uncontrolled arrhythmias (e.g., ventricular arrhythmias, high-grade atrioventricular (AV)-block, supra-ventricular arrhythmias which are not adequately rate-controlled)
    • Arrhythmias that require current treatment with the following anti-arrhythmic drugs: flecainide, moricizine or propafenone
    • A myocardial infarction within the last 6 months or unstable angina
  8. Prior radiotherapy to the only area of measurable disease
  9. Radiotherapy within 2 weeks prior to Cycle 1 Day 1 (related radiotherapy toxicities must be ≤ Grade 1)
  10. Major surgery (unrelated to NSCLC) within 4 weeks prior to Cycle 1 Day 1
  11. Women who are pregnant or lactating
  12. Significant weight loss (≥10% body weight) within the 4 weeks prior to Cycle 1 Day 1
  13. Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, severe or systemic infection, or psychiatric illness/social situations that would limit compliance with study requirements
  14. Other medications, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study

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