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AUY922 for Advanced ALK-positive NSCLC

This study is currently recruiting participants.
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Alice Shaw, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01752400
First received: December 7, 2012
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer
 Drug: AUY922
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the best objective response rate to AUY922


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Defined from date of study entry to date of progression or death, whichever comes first.

  • Disease control rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate disease control rate, which includes complete responses, partial responses or stable disease

  • Number of patients who develop adverse events on AUY922 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To determine the safety and tolerability of AUY922

  • Number of patients with concurrent KRAS mutations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess the prevalence of concurrent KRAS mutations in a ALK-positive NSCLC population

  • ALK translocation variant type [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Correlation of ALK translocation variant type and objective response

  • ALK mutation status [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Estimate the median overall survival


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752400

Contacts
Contact: Alice Shaw, MD, PhD 6177244000 ashaw1@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alice Shaw, MD, PhD     617-724-4000     ashaw1@partners.org    
Principal Investigator: Alice Shaw, MD            
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Leena Gandhi, MD, PhD     617-632-6049     lgandhi@partners.org    
Principal Investigator: Leena Gandhi, MD, PhD            
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Leena Gandhi, MD, PhD     617-632-6049     lgandhi@partners.org    
Principal Investigator: Leena Gandhi, MD, PhD            
Beth Isreal Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Daniel Costa, MD     617-667-9236     dbcosta@bidmc.harvard.edu    
Principal Investigator: Daniel Costa, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Alice Shaw, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Alice Shaw, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01752400     History of Changes
Other Study ID Numbers: 12-458
Study First Received: December 7, 2012
Last Updated: April 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Advanced

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

ClinicalTrials.gov processed this record on June 18, 2013