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2N-12-6: A Study of HSP90 Inhibitor AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)

Description

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 at any time.

Phase

Phase 1/2 - for trials that are a combination of phases 1 and 2.

Inclusion and Exclusion 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

  • 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

Sites

  • California

    • USC Norris Comprehensive Cancer Center, Los Angeles, California, 90033
    • Innovative Clinical Research Institute, Whittier, California, 90603
    • UCLA Medical Center, Santa Monica, California, 90404
    • UCLA Medical Center, Los Angeles, California, 90095
    • Sharp Clinical Oncology Research-Sharp Memorial Hospital, San Diego, California, 92123
  • Arizona

    • Mayo Clinic-Scottsdale, Scottsdale, Arizona, 85259
    • Mayo Clinic-Scottsdale, Scottsdale, Arizona, 85259
  • Oregon

    • Providence Portland Medical Center, Portland, Oregon, 97213
  • Washington

    • Swedish Cancer Institute, Seattle, Washington, 98104
    • University of Washington Medical Center, Seattle, Washington, 98109
    • University of Washington Medical Center, Seattle, Washington, 98109
  • Texas

    • University of Texas Southwestern Medical Center, Dallas, Texas, 75390
  • Nebraska

    • University of Nebraska Medical Center Eppley Cancer Center, Omaha, Nebraska, 68198
  • Minnesota

    • Mayo Clinic-Rochester, Rochester, Minnesota, 55905
  • Missouri

    • Washington University School of Medicine, St. Louis, Missouri, 63110
  • Tennessee

    • The West Clinic, Memphis, Tennessee, 38120
    • Sarah Cannon Research Institute, Nashville, Tennessee, 37203
  • Wisconsin

    • University of Wisconsin-Carbone Cancer Center, Madison, Wisconsin, 53579
  • Illinois

    • University of Chicago, Chicago, Illinois, 60637
    • Northwestern University The Feinberg School of Medicine, Chicago, Illinois, 60611
  • Indiana

    • Indiana University Melvin and and Bren Simon Cancer Center, Indianapolis, Indiana, 46202
  • Ohio

    • University of Cincinnati Cancer Institute, Cincinnati, Ohio, 45267
    • Oncology Hematology in Cincinnati, Cincinnati, Ohio, 45242
  • France

    • Hopital Saint Antoine, Creteil Cedex, 94010
    • Hopital Saint Antoine, Creteil Cedex, 94010
    • CHRU de Lille, Lille cedex, 59037
    • Hopital Tenon, Paris, 75020
    • Centre Hospitalier de Grenoble, Grenoble, 38043
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