AUY922 for Advanced ALK-positive NSCLC
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: AUY922
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced

Summary:

      This research study is a Phase II clinical trial, which tests the safety and effectiveness of
      an investigational drug to learn whether the drug works in treating a specific cancer.
      "Investigational" means that the drug is being studied and that research doctors are trying
      to find out more about it-such as the safest dose to use, the side effects it may cause and
      if the drug is effective for treating your type of cancer. It also means that the FDA has not
      yet approved the drug for your type of cancer or for any use outside of research studies.

      It has been found that some people with NSCLC have a change (mutation) in a certain gene
      called the ALK gene. This mutated gene helps cancer cells grow. There is a drug (crizotinib)
      that has been approved by the FDA for the treatment of people with NSCLC who have mutations
      in the ALK gene. Most people respond to crizotinib initially. Over time, however, patients
      may stop responding (become resistant) to crizotinib because of additional changes in the ALK
      gene that makes crizotinib ineffective.

      AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This
      drug has been used in other research studies. Information from those other research studies
      suggests that AUY922 may be effective in killing cancer cells that have become resistant to
      drugs like crizotinib. Only participants with changes in the ALK gene will be allowed to
      participate in this study.

      The purpose of this study is to test the safety of AUY922 and determine how well AUY922
      treats participants with advanced, ALK-positive NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced NSCLC

          -  Tumor characterized by abnormalities in ALK

          -  Required to provide archival tissue in the form of 5 formalin fixed paraffin embedded
             sections

          -  Have acquired resistance to treatment with an ALK-TKI

          -  At least one measurable lesion as defined by RECIST criteria

          -  Life expectancy of at least 12 weeks

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Discontinued ALK TKI more than four weeks prior to enrollment

          -  Unresolved diarrhea greater than or equal to CTCAE grade 1

          -  Not willing to use double barrier methods of contraception

          -  Prior anti-neoplastic treatment with any HSP90 or HDAC inhibitor compound

          -  Have received cytoxic chemotherapy in the intervening period since discontinuation of
             an ALK-TKI

          -  Have undergone major surgery within 2 weeks prior to starting study drug

          -  Any concurrent or uncontrolled illness

          -  Any known disorders due to a deficiency in bilirubin glucuronidation

          -  Taking therapeutic doses of warfarin

          -  Any serious cardiac disorders or abnormalities

          -  Concurrent malignancies or invasive cancers diagnosed within the past 2 years except
             for adequately treated basal cell cancer of the skin or in situ cancers

          -  Known to be HIV positive

          -  Known hypersensitivity to any of the study drugs or their excipients

          -  Participation in another clinical study within 30 days before the first study
             treatment