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

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ClinicalTrials.gov Identifier: NCT03228186
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Pevonedistat Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Pevonedistat (TAK-924) Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Pevonedistat plus Docetaxel
Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle
Drug: Pevonedistat
25mg/m2 days 1, 3, 5
Other Name: TAK-924

Drug: Docetaxel
75mg/m2 day 1




Primary Outcome Measures :
  1. The percentage of patients that respond to treatment [ Time Frame: Up to 2 Years ]

    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 :
  1. Median Progression Free Survival Time [ Time Frame: Up to 2 Years ]

    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.


  2. Median Overall Survival Time [ Time Frame: Up to 2 Years ]
  3. The number of patients who achieve stable disease [ Time Frame: Up to 2 Years ]

    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.


  4. The number of toxicities by system organ class [ Time Frame: Up to 30 days post treatment ]
    All recorded toxicities will be listed and tabulated by system organ class. The NCI CTCAE version 4.03 will be utilized for AE reporting.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT03228186


Contacts
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Contact: Gregory Kalemkerian, M.D. 734-647-8921 kalemker@umich.edu

Locations
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United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48187
Contact: Gregory Kalemkerian, M.D.    734-647-8921    kalemker@umich.edu   
Principal Investigator: Gregory Kalemkerian, M.D.         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Gregory Kalemkerian, M.D. University of Michigan Rogel Cancer Center
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03228186    
Other Study ID Numbers: UMCC 2017.063
HUM00131436 ( Other Identifier: University of Michigan )
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Pevonedistat
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors