Non-small Cell Lung CancerPhase 2NCT03228186
Trial of Pevonedistat Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Pevonedistat and Docetaxel in people with Non-small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Pevonedistat and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 4 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48187
About this study
Official title: Phase II Trial of Pevonedistat (TAK-924) Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
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
- Being tested
- Pevonedistat, Docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PevonedistatDrug
Also called TAK-924
25mg/m2 days 1, 3, 5
DocetaxelDrug
75mg/m2 day 1
| Study group | Role | What they receive |
|---|---|---|
| Pevonedistat plus Docetaxel | Experimental | Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Receives: Drug: Pevonedistat; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 Years
Secondary outcomes (4)
Median Progression Free Survival Time
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.
Measured: Up to 2 Years
Median Overall Survival Time
Overall survival is defined as the duration of time from start of treatment to time of passing.
Measured: Up to 2 Years
The Number of Patients Who Achieve Stable Disease
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.
Measured: Up to 2 Years
The Number of Toxicities by System Organ Class
All recorded toxicities will be listed and tabulated by system organ class. The NCI CTCAE version 4.03 will be utilized for AE reporting.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start5 Mar 2018
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Why it stopped: Pharmaceutical company discontinued the study drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Kalemkerian, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228186
- Sponsor's protocol ID
- UMCC 2017.063
- Other IDs
- HUM00131436
- Status last verified
- Oct 2023
- First submitted
- 21 Jul 2017
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Pevonedistat (TAK-924) Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03228186
- Acronym / sponsor ID
- UMCC 2017.063
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pharmaceutical company discontinued the study drug.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pevonedistat plus Docetaxel | Experimental | Drug: Pevonedistat, Drug: DocetaxelPevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PevonedistatAlso: TAK-92425mg/m2 days 1, 3, 5 | Drug | Pevonedistat plus Docetaxel |
| Docetaxel75mg/m2 day 1 | Drug | Pevonedistat plus Docetaxel |
Primary outcome
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.
4 secondary outcomes
Median Progression Free Survival Time
Time frame: Up to 2 Years
Median Overall Survival Time
Time frame: Up to 2 Years
The Number of Patients Who Achieve Stable Disease
Time frame: Up to 2 Years
The Number of Toxicities by System Organ Class
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Kalemkerian, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pevonedistat and Docetaxel in people with Non-small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Patients That Respond to Treatment (time frame: Up to 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.