Clinical Trials /

Trial of Pevonedistat Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

NCT03228186

Description:

This study is a single institution Phase II single arm trial to assess the efficacy of the combination of pevonedistat plus docetaxel in patients with previously treated advanced NSCLC (non-small cell lung cancer).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trial of Pevonedistat Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
  • Official Title: Phase II Trial of Pevonedistat (TAK-924) Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2017.063
  • SECONDARY ID: HUM00131436
  • NCT ID: NCT03228186

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
PevonedistatTAK-924Pevonedistat plus Docetaxel
DocetaxelPevonedistat plus Docetaxel

Purpose

This study is a single institution Phase II single arm trial to assess the efficacy of the combination of pevonedistat plus docetaxel in patients with previously treated advanced NSCLC (non-small cell lung cancer).

Trial Arms

NameTypeDescriptionInterventions
Pevonedistat plus DocetaxelExperimentalPevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle
  • Pevonedistat
  • Docetaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Patients 18 years of age or older

          -  Histologically confirmed stage IV NSCLC (adenocarcinoma, squamous cell carcinoma,
             large cell carcinoma, or not otherwise specified) or recurrent NSCLC not amenable to
             curative therapy

          -  Patients must have already received platinum-based chemotherapy; they may have also
             received prior immunotherapy or targeted therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (an attempt to
             quantify cancer patients' general well-being and activities of daily life. The score
             ranges from 0 to 5 where 0 is asymptomatic and 5 is death.)

          -  Clinical laboratory values within appropriate parameters

          -  Female patients who are of childbearing potential and all males must agree to practice
             true abstinence or use effective methods of contraception

          -  Patients must be able to understand and sign the informed consent.

          -  Patients must have measurable disease as defined by RECIST v1.1 criteria

          -  It is preferable that patients have an adequate tissue sample available

        Exclusion Criteria:

          -  Treatment with any investigational products within 4 weeks before the first dose of
             any study drug

          -  Any serious medical or psychiatric illness that could, in the investigator's opinion,
             potentially interfere with the completion of study procedures

          -  Active uncontrolled infection or severe infectious disease, such as severe pneumonia,
             meningitis, or septicemia that require IV antibiotics within 2 weeks of starting study
             treatment

          -  Major surgery within 14 days before the first dose of any study drug or a scheduled
             surgery during study period

          -  Diagnosed or treated for another malignancy within 2 years before randomization or
             previously diagnosed with another malignancy and have any evidence of residual
             disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are
             not excluded if they have undergone resection.

          -  Life-threatening illness unrelated to cancer

          -  Patients with uncontrolled coagulopathy or bleeding disorder

          -  Known human immunodeficiency virus (HIV) seropositivity

          -  Known hepatitis B surface antigen seropositivity or known or suspected active
             hepatitis C infection

          -  Known hepatic cirrhosis or severe pre-existing hepatic impairment

          -  Known cardiopulmonary disease

          -  Uncontrolled high blood pressure (ie, systolic blood pressure > 180 mm Hg, diastolic
             blood pressure > 95 mm Hg)

          -  Prolonged rate corrected QT (QTc) interval ≥ 500 msec, calculated according to
             institutional guidelines

          -  Interstitial lung disease or pulmonary fibrosis

          -  Systemic antineoplastic therapy or radiotherapy for other malignant conditions within
             14 days before the first dose of any study drug, except for hydroxyurea.

          -  Symptomatic or history of untreated brain or leptomeningeal metastases. Treated
             patients should be neurologically stable for 4 weeks after completion of appropriate
             therapy. Patients should be off steroids at least 3 days prior to start of therapy on
             clinical trial.

          -  Treatment with clinically significant metabolic enzyme inducers within 14 days before
             the first dose of the study drug. Clinically significant metabolic enzyme inducers are
             not permitted during this study (see Appendix III for more details).

          -  Female patients who are lactating, breastfeeding, or have a positive pregnancy test

          -  Female patients who intend to donate eggs (ova) during the course of this study or 4
             months after receiving their last dose of study drug(s).

          -  Male patients who intend to donate sperm during the course of this study or 4 months
             after receiving their last dose of study drug(s).

          -  Known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80

          -  Prior therapy with docetaxel for non-small cell lung cancer

          -  Peripheral neuropathy of CTCAE v4.03 grade ≥ 2
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The percentage of patients that respond to treatment
Time Frame:Up to 2 Years
Safety Issue:
Description:Response is defined as either Partial Response or Complete Response. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. Complete Response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

Secondary Outcome Measures

Measure:Median Progression Free Survival Time
Time Frame:Up to 2 Years
Safety Issue:
Description:Progression-free survival is defined as the duration of time from start of treatment to time of progression. Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Measure:Median Overall Survival Time
Time Frame:Up to 2 Years
Safety Issue:
Description:
Measure:The number of patients who achieve stable disease
Time Frame:Up to 2 Years
Safety Issue:
Description:Stable disease rate will be reported as the count and proportion of patients who achieve stable disease. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started.
Measure:The number of toxicities by system organ class
Time Frame:Up to 30 days post treatment
Safety Issue:
Description:All recorded toxicities will be listed and tabulated by system organ class. The NCI CTCAE version 4.03 will be utilized for AE reporting.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Michigan Rogel Cancer Center

Last Updated

June 24, 2020