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Trial record 67 of 113 for:    acyclovir

Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D

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ClinicalTrials.gov Identifier: NCT01833143
Recruitment Status : Active, not recruiting
First Posted : April 16, 2013
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE April 11, 2013
First Posted Date  ICMJE April 16, 2013
Last Update Posted Date May 3, 2019
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
efficacy of single-agent subcutaneous bortezomib [ Time Frame: 2 years ]
The following evaluations will be conducted to assess the efficacy of bortezomib - radiographic response rate by RECIST v1.1
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2013)
efficacy of single-agent subcutaneous bortezomib [ Time Frame: 2 years ]
The following evaluations will be conducted to assess the efficacy of bortezomib - radiographic response rate by RECIST v1.1, progression-free survival, and overall survival.
Change History Complete list of historical versions of study NCT01833143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
  • Efficacy [ Time Frame: 2 years ]
    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 ]
    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,).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2013)
  • response [ Time Frame: 2 years ]
    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 ]
    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,.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D
Official Title  ICMJE A Phase 2 Trial of Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Bortezomib
  • Drug: Acyclovir
Study Arms  ICMJE Experimental: Bortezomib
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.
Interventions:
  • Drug: Bortezomib
  • Drug: Acyclovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2013)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologic or cytologic evidence of non-small cell lung cancer (NSCLC)
  • Documented KRAS mutation
  • History of smoking < 100 cigarettes (never-smoker) OR patient with a KRAS G12D mutation regardless of smoking history
  • Clinical stage IIIB/IV or recurrent/medically inoperable NSCLC
  • Age ≥ 18 years
  • Three (3) weeks since last chemotherapy, and three (3) weeks since prior radiation therapy and recovered from treatment
  • Karnofsky performance status ≥ 70%
  • Adequate hematologic, and/or hepatic function WBC ≥ 3,000/ul or absolute neutrophil count ≥ 1,000/ul Hemoglobin ≥ 9.0 g/dl Platelet count ≥ 100,000/ul AST ≤ 2.0 X ULN (upper limit of normal)
  • Total bilirubin ≤1.5 x ULN Measurable indicator lesions by RECIST v1.1 criteria.
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of bortezomib, or agree to completely abstain from heterosexual intercourse.
  • Male subjects must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.

Exclusion Criteria:

  • Uncontrolled central nervous system metastases defined as any lesion which is either a. symptomatic, or requiring escalating doses of corticosteroids
  • Significant medical history or unstable medical condition such as uncontrolled diabetes myocardial infarction within 6 months prior to enrollment New York Heart Association Class III or IV heart failure severe uncontrolled ventricular arrythmias uncontrolled angina ECG evidence of acute ischemia or active conduction system abnormalities
  • Baseline ≥ grade 2 peripheral neuropathy by CTCAE v 4.0 (Appendix B)
  • Known hypersensitivity to boron or mannitol
  • Female patients who are pregnant/lactating or have a positive serum or urine β-hCG pregnancy test
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • No active concurrent malignancy, with the exception of in-situ malignancy completely resected basal cell carcinoma or squamous cell carcinomas of the skin low-risk prostate cancer after curative therapy
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01833143
Other Study ID Numbers  ICMJE 12-222
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Millennium Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Gregory Riely, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP