Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Pevonedistat

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

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

Gregory Kalemkerian, M.D.

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

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

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.

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.

Overall survival is defined as the duration of time from start of treatment to time of passing.

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.

All recorded toxicities will be listed and tabulated by system organ class. The NCI CTCAE version 4.03 will be utilized for AE reporting.

University of Michigan Rogel Cancer Center

No patients died while within the Adverse Event Reporting windows

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

Pevonedistat: 25mg/m2 days 1, 3, 5

Docetaxel: 75mg/m2 day 1

Pevonedistat Plus Docetaxel

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Gregory Kalemkerian, MD

27 patients participated in the trial long enough to be considered evaluable for this outcome measure

The Percentage of Patients That Respond to Treatment

Median Progression Free Survival Time

Median Overall Survival Time

The Number of Patients Who Achieve Stable Disease

Blood and Lymphatic system disorders- grade 3

Gastrointestinal disorders- grade 3

General disorders and administration site conditions- grade 3

hepatobiliary disorders- grade 3

infections and infestations- grade 3

infections and infestations- grade 4

investigations- grade 3

investigations- grade 4

metabolism and nutrition disorders- grade 3

nervous system disorders- grade 3

respiratory, thoracic and mediastinal disorders- grade 3

Skin and subcutaneous tissue disorders- grade 3

Percentage of Grade 3-5 Adverse Events classified according to the Row Titles. The investigations group represents adverse events due to treatment drugs.

The Number of Toxicities by System Organ Class

Overall Study

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial