CRC 13086: A Study of Heat Shock Protein 90 (HSP90) Inhibitor AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-Small Cell Lung Cancer (NSCLC)

The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.

This is a 3-part phase 1-2 study in patients with anaplastic lymphoma kinase (ALK) + or other potentially crizotinib-sensitive NSCLC who have been receiving crizotinib. Part A is a single-arm, Phase 1, open-label, dose escalation design in patients with NSCLC who have already been receiving crizotinib for at least 8 weeks and continue to tolerate therapy. Part B is a Phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + AT13387 at the maximum tolerated dose established in Part A. Part C is an open-label, randomized, Phase 2, Simon's 2 stage design evaluating single agent AT13387 or combination AT13387 + crizotinib at the MTD established in Part A in patients who progressed on crizotinib...

July 16, 2014
Cancer (Oncology) - Lung, Cancer (Oncology)
Howard (Jack) West, M.D.
Swedish Cancer Institute

Inclusion Criteria:

  • Men or women 18 years of age or older
  • Must have Non-small Cell Lung Cancer with ALK+ mutation or other mutations or rearrangements potentially sensitive to crizotinib
  • Measurable disease
  • Must have been receiving or have received crizotinib
  • Have adequate cardiac, bone marrow, liver and kidney function
  • Must be willing and able to provide written informed consent and comply with the protocol and study procedures

Exclusion Criteria:

  • Prior anti-cancer treatment with any HSP90 inhibitor
  • Have received chemotherapy, radiation therapy or other anticancer treatment other than crizotinib within 3 weeks prior to the first dose of study drug
  • Prior malignancy other than adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, low-grade cervical cancer, non-metastatic prostate cancer, or have been disease-free for at least 3 years
  • Abnormal heart function
  • Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors
  • Hypersensitivity of AT13387 or other components of the drug product
  • Treatment with an investigational drug within 3 weeks prior to the first dose of study drug
  • Severe systemic diseases or active uncontrolled infections
  • Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
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