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AUY922 for Advanced ALK-positive NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01752400
Recruitment Status : Active, not recruiting
First Posted : December 19, 2012
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Alice Shaw, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: AUY922 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Trial of AUY922, an HSP90 Inhibitor, in Patients With ALK-Rearranged Advanced Non-Small Cell Lung Cancer and Acquired Resistance to Prior ALK Tyrosine Kinase Inhibition
Study Start Date : January 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AUY922
Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
Drug: AUY922

Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 2 years ]
    Evaluate the best objective response rate to AUY922

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
    Defined from date of study entry to date of progression or death, whichever comes first.

  2. Disease control rate [ Time Frame: 2 years ]
    Evaluate disease control rate, which includes complete responses, partial responses or stable disease

  3. Number of patients who develop adverse events on AUY922 [ Time Frame: 2 years ]
    To determine the safety and tolerability of AUY922

  4. Number of patients with concurrent KRAS mutations [ Time Frame: 2 years ]
    To assess the prevalence of concurrent KRAS mutations in a ALK-positive NSCLC population

  5. ALK translocation variant type [ Time Frame: 2 years ]
    Correlation of ALK translocation variant type and objective response

  6. ALK mutation status [ Time Frame: 2 years ]
    Evaluate the number of secondary ALK mutations or ALK amplification as a mechanism of resistance in pre-treatment and post-treatment biopsies, and assess relationship to outcomes

  7. Overall survival [ Time Frame: 2 years ]
    Estimate the median overall survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752400

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Alice Shaw, MD, PhD Massachusetts General Hospital

Responsible Party: Alice Shaw, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01752400     History of Changes
Other Study ID Numbers: 12-458
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Alice Shaw, Massachusetts General Hospital:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms