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

NCT03228186 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: UMCC 2017.063HUM00131436
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients That Respond to Treatment

  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.

  Up to 2 Years

Secondary Outcomes (4)

• Median Progression Free Survival Time

  Up to 2 Years

• Median Overall Survival Time

  Up to 2 Years

• The Number of Patients Who Achieve Stable Disease

  Up to 2 Years

• The Number of Toxicities by System Organ Class

  up to 30 days post last study drug dose, patients were allowed to stay on study drug treatment until progression. Data was collected over 3.5 years.

Study Arms (1)

Pevonedistat plus Docetaxel

EXPERIMENTAL

Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle

Drug: Pevonedistat; Drug: Docetaxel

Interventions

Pevonedistat DRUG

25mg/m2 days 1, 3, 5

Also known as: TAK-924

Pevonedistat plus Docetaxel

Docetaxel DRUG

75mg/m2 day 1

Pevonedistat plus Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48187, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pevonedistat; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Gregory Kalemkerian, MD
• Organization: Rogel Cancer Center

kalemker@med.umich.edu

734-647-8921

Study Officials

• Gregory Kalemkerian, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 24, 2017
• Study Start: March 5, 2018
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-10

Locations

US (1)