Pemetrexed Disodium and Hsp90 Inhibitor AUY922 in Treating Patients With Previously Treated Stage IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01784640|
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Non-small Cell Lung Cancer Squamous Cell Lung Cancer Stage IV Non-small Cell Lung Cancer||Drug: Hsp90 inhibitor AUY922 Drug: pemetrexed disodium Other: pharmacological study Other: laboratory biomarker analysis||Phase 1|
I. Evaluate the safety and tolerability of escalating doses of AUY922 (Hsp90 inhibitor AUY922) when given with pemetrexed (pemetrexed disodium) 500 mg/m^2 in participants with previously-treated stage IV non-squamous, non-small cell lung cancer (NSCLC).
I. Determine the objective tumor response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants with previously treated non-squamous NSCLC treated with pemetrexed and AUY922.
II. Evaluate the pharmacokinetic profile of pemetrexed and AUY922. III. Evaluate toxicity, including visual toxicity, in participants treated with AUY922 and pemetrexed.
IV. Analyze tumor-tissue biomarkers for potential correlation with response.
OUTLINE: This is a dose-escalation study of Hsp90 inhibitor AUY922.
Patients receive Hsp90 inhibitor AUY922 intravenously (IV) over 60 minutes weekly and pemetrexed disodium IV over 15 minutes every 3 weeks. Courses repeat every 21 days for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IB Dose-Escalation Study of Pemetrexed and AUY922 in Previously-Treated Patients With Metastatic Non-Squamous, Non-Small Cell Lung Cancer|
|Actual Study Start Date :||January 31, 2014|
|Actual Primary Completion Date :||October 11, 2018|
|Actual Study Completion Date :||October 11, 2018|
Experimental: Treatment (Hsp90 inhibitor AUY922, pemetrexed disodium)
Patients receive Hsp90 inhibitor AUY922 IV over 60 minutes weekly and pemetrexed disodium IV over 15 minutes every 3 weeks. Courses repeat every 21 days for 6 months in the absence of disease progression or unacceptable toxicity.
Drug: Hsp90 inhibitor AUY922
Other Name: AUY922
Drug: pemetrexed disodium
Other: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
- Incidence of adverse events (AEs) as assessed by National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ]Safety will be assessed through tabulation, grading and attribution of serious adverse events (SAEs) and AEs.
- Tumor response rate according to RECIST version 1.1 [ Time Frame: Up to 30 days after completion of study treatment ]The proportion of ever achieving a clinical response will be estimated and constructed with an exact one-sided 90% confidence interval to identify the likely range for the underlying tumor response rate. Clinical response will be correlated with biomarkers using a variety of analytic techniques.
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): NCT01784640
|United States, California|
|Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Edward Garon||Jonsson Comprehensive Cancer Center|