Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D
The purpose of this study is to test the drug Bortezomib to see how well it works. The investigators want to find out what effects, good or bad, it has on patients with a limited smoking history or who have a specific mutation associated with their lung cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Trial of Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D|
- efficacy of single-agent subcutaneous bortezomib [ Time Frame: 2 years ] [ Designated as safety issue: No ]The following evaluations will be conducted to assess the efficacy of bortezomib - radiographic response rate by RECIST v1.1
- Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]Secondary endpoints of progression free survival, 8-week stable disease, and overall survival will be evaluated according to RECIST v.1.1 criteria as well.
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE v4.0,).
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Bortezomib will be administered by subcutaneous injection twice weekly for 2 weeks (Days 1, 4, 8, and 11) at 1.3 mg/m2/dose followed by a 10-day rest period for a 21 day cycle. Dose modifications are permitted as per a prescribed algorithm. Acyclovir at 400mg daily is recommended as prophylaxis for herpes zoster. Restaging scans, with evaluation of response, will be done every 2 cycles (6 weeks of treatment ± 7 days). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 2 weeks, or at the discretion of the treating physician or patient.
|Drug: Bortezomib Drug: Acyclovir|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01833143
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan-Kettering Cancer Center at Mercy Medical Center|
|Rockville Centre, New York, United States, 11570|
|Memoral Sloan Kettering Cancer Center at Phelps|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Gregory Riely, MD, PhD||Memorial Sloan Kettering Cancer Center.|