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NCT01833143

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

Completed Phase 2 Results posted Last updated 4 August 2020
What this trial tests

Phase 2 trial testing Bortezomib in Non-Small Cell Lung Cancer in 17 participants. Completed in 28 August 2019.

Timeline
11 April 2013
Primary endpoint
28 August 2019
28 August 2019

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment17
Start date11 April 2013
Primary completion28 August 2019
Estimated completion28 August 2019
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Radiographic Response Rate Primary · 2 years

The following evaluations will be conducted to assess the efficacy of bortezomib - radiographic response rate by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

GroupValue95% CI
Bortezomib1
Bortezomib6
Bortezomib10
Progression Free Survival Secondary · 2 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

GroupValue95% CI
Bortezomib11 – 6
Participants Evaluated for Toxicity Secondary · 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,).

GroupValue95% CI
Bortezomib17
Overall Survival Secondary · 2 years
GroupValue95% CI
Bortezomib136 – 30

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Bortezomib
Serious: 4/17 (24%)
Deaths: 12/17

Serious adverse events (4 terms)

ReactionSystemBortezomib
DyspneaRespiratory, thoracic and mediastinal disorders
FeverGeneral disorders
LeukocytosisBlood and lymphatic system disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
Other adverse events (25 terms — click to expand)

ReactionSystemBortezomib
FatigueGeneral disorders
DiarrheaGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
ConstipationGastrointestinal disorders
NauseaGastrointestinal disorders
Papulopustular rashSkin and subcutaneous tissue disorders
HeadacheNervous system disorders
Localized edemaGeneral disorders
FeverGeneral disorders
Injection site reactionGeneral disorders
Mucositis oralGastrointestinal disorders
Peripheral motor neuropathyNervous system disorders
Peripheral sensory neuropathyNervous system disorders
Platelet count decreasedInvestigations
VomitingGastrointestinal disorders
Back painMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
DepressionPsychiatric disorders
Dry mouthGastrointestinal disorders
Eye painEye disorders
Flu like symptomsGeneral disorders
HemorrhoidsGastrointestinal disorders
HypothyroidismEndocrine disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Rash maculo-papularSkin and subcutaneous tissue disorders

Most-reported serious reactions: Dyspnea, Fever, Leukocytosis, Pneumonitis.

Data from ClinicalTrials.gov NCT01833143 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Inflammation and tumor progression: signaling pathways and targeted intervention.
    Zhao H, Wu L, Yan G, Chen Y, et al · · 2021 · cited 1932× · PMID 34248142 · DOI 10.1038/s41392-021-00658-5
  2. NF-κB signaling in inflammation and cancer.
    Zhang T, Ma C, Zhang Z, Zhang H, et al · · 2021 · cited 386× · PMID 34977871 · DOI 10.1002/mco2.104
  3. KRAS oncogene in non-small cell lung cancer: clinical perspectives on the treatment of an old target.
    Román M, Baraibar I, López I, Nadal E, et al · · 2018 · cited 217× · PMID 29455666 · DOI 10.1186/s12943-018-0789-x
  4. Small Molecule NF-κB Pathway Inhibitors in Clinic.
    Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
  5. Molecular pathways and therapeutic targets in lung cancer.
    Shtivelman E, Hensing T, Simon GR, Dennis PA, et al · · 2014 · cited 150× · PMID 24722523 · DOI 10.18632/oncotarget.1891
  6. A RAS renaissance: emerging targeted therapies for KRAS-mutated non-small cell lung cancer.
    Vasan N, Boyer JL, Herbst RS. · · 2014 · cited 83× · PMID 24893629 · DOI 10.1158/1078-0432.ccr-13-1762
  7. The proteasome as a druggable target with multiple therapeutic potentialities: Cutting and non-cutting edges.
    Tundo GR, Sbardella D, Santoro AM, Coletta A, et al · · 2020 · cited 78× · PMID 32442437 · DOI 10.1016/j.pharmthera.2020.107579
  8. KRAS oncogene in lung cancer: focus on molecularly driven clinical trials.
    Kempf E, Rousseau B, Rousseau B, Besse B, et al · · 2016 · cited 71× · PMID 26929424 · DOI 10.1183/16000617.0071-2015

Verify or expand the search:

Other trials of Bortezomib

Trials testing the same drug.

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01833143.

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