Non Small Cell Lung Cancer Clinical Trial
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
Verified date | March 2018 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | November 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Isreal Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate | The number of participants that achieved either a complete response (CR) or a partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
Baseline and then every six weeks (± 7 days), until the time of disease progression | |
Secondary | Progression-free Survival | Progression free survival is measured as the number of months from date of study entry to date of progression or death, whichever comes first. Progression is assessed using RECIST v1.1. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression. |
From the start of treatment until the time of death or progression | |
Secondary | Disease Control Rate | The number of participants that achieved disease control, which includes complete responses, partial responses or stable disease as assessed by RECIST v1.1 Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Baseline and then every six weeks (± 7 days), until the time of disease progression | |
Secondary | Number of Participants Who Develop Adverse Events on AUY922 | The number of participants that developed any grade adverse event as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4) | From the start of treatment until 30 days after last dose was received | |
Secondary | Number of Participants With Concurrent KRAS Mutations | Baseline | ||
Secondary | ALK Translocation Variant Type | Baseline | ||
Secondary | ALK Mutation Status | The number of secondary ALK mutations or ALK amplification as a mechanism of resistance in pre-treatment and post-treatment biopsies. | Baseline, end of treatment | |
Secondary | Median Overall Survival | The median duration of time from the start of treatment until the time of death or until the participant withdraws participation in the trial. | From the start of treatment until death or withdrawal from the study |
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