Non-Small Cell Lung Cancer (NSCLC)Phase 2NCT02642939
Study of Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Mifepristone in people with Non-Small Cell Lung Cancer (NSCLC), run by Check, Jerome H., M.D., Ph.D. at 1 site in United States.
Trial summary
This is a non-randomized, multicenter, single-stage phase II study of mifepristone in patients with advanced or metastatic NSCLC who have failed two or more previous chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 15 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Each patient must meet the following criteria to be enrolled in the study
- Must understand and voluntarily sign an informed consent
- Age ≥ 18 years at the time of signing the informed consent
- Histological or cytological documented diagnosis of locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC
- Patients must have evidence of disease, measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Patients shall provide results of tumor testing for epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement, and if positive for EGFR mutation or ALK rearrangement shall have received appropriate targeted therapy prior to enrollment. If not previously tested, EGFR and ALK testing must be performed prior to study entry.
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- Patients shall have progressed after two or more previous chemotherapy regimens for metastatic or locally advanced disease
- Patients must have recovered from any toxic effects and at least 3-4 weeks must have elapsed from the last dose of previous therapy, prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
- Life expectancy of at least 12 weeks
- Patients must have adequate bone marrow and renal/hepatic function at the screening visit, defined as:
- Absolute neutrophil count ≥ 1,500/mm3 without granulocyte colony-stimulating factor (G-CSF) support within 7 days preceding the lab assessment
- Platelet count ≥ 100,000/mm3, without transfusion within 7 days preceding the lab assessment
- Hemoglobin ≥ 9 g/dL, without transfusion support within 7 days preceding the lab assessment
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)
- Total serum bilirubin ≤ 1.5 times ULN
- Serum creatinine ≤ ULN
- Potassium and magnesium levels within normal limits. Patients with potassium or magnesium below the lower limit of normal must have levels corrected to normal by supplementation prior to starting study drug
- Disease-free period of > 3 years from any other previous malignancies, excluding curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
- Female patient of childbearing potential must have a negative serum pregnancy test. Sexually active female patient f childbearing potential must be willing to use non-hormonal contraception, including condom use by male partner, and barrier method by the female partner (diaphragm or cervical cap both with spermicide) during the treatment period and for at least 3 months after the last dose of the study drug. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or are surgically sterile (status post tubal ligation or hysterectomy).
- Patients must be able and willing to comply with the study visit schedule and study procedures
- Able to take oral medications.
Who cannot join
- Patients who meet any of the following criteria will not be permitted entry to the study:
- Pregnant or breast-feeding
- Women with a history of unexplained vaginal bleeding.
- Women with uterine hyperplasia - in pre-menopausal women hyperplasia >18mm and in post-menopausal women hyperplasia of >10mm Prior therapy with mifepristone
- Prior therapy with mifepristone
- Patients who have had recent systemic cytotoxic therapies or radiotherapy within 14 days prior to day 1 of cycle 1
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- Use of cytotoxic chemotherapeutic agents, erythropoiesis-stimulating agents (ESA), or experimental agents (agents that are not commercially available) within 30 days of the first day of study drug treatment.
- Patients who have had any major surgery within 4 weeks prior to day 1 of cycle 1, or minor surgery within 2 weeks prior to day 1 of cycle 1
- For two weeks prior to first day of study drug treatment, administration of any of the following cytochrome P450 3A (CYP3A) inducers: phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, St. John's Wort; or CYP3A inhibitors: ketoconazole, itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir amprenavir, fosamprenavir, boceprevir, clarithromycin, conivaptan, lopinavir, posaconazole, saquinavir, telaprevir, telithromycin, or voriconazole
- Patients who are taking simvastatin or lovastatin. Patients should be switched to alternative therapies a minimum of 2 weeks before starting study drug
- Patients who have been treated with an investigational agent within 21 days prior to day 1 of cycle 1.
- Concomitant use of biological agents including growth factors
- Patients who require treatment with systemic corticosteroids for serious medical conditions or illnesses (e.g. immunosuppression after organ transplantation)
- Chronic liver disease as indicated by Child-Pugh score A (6) or greater
- History of significant cardiac disease. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease; mean QTc interval > 480 msec on at least two separate electrocardiograms (ECGs) prior to study start; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea)
- Any other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation
- Concomitant use of progestational agents
- Known history of human immunodeficiency virus (HIV) positivity
- In the opinion of the Investigator, any serious medical condition or psychiatric illness that will prevent the patient from signing the informed consent or will place the patient at unacceptable risk if he/she participates in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper Institute for Reproductive Hormonal Disorders
Melrose Park, Pennsylvania, 19027
About this study
Official title: A Phase II Study of Treatment With Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Two or More Previous Chemotherapy Regimens
This is a non-randomized, multicenter, single-stage phase II study of mifepristone in patients with advanced or metastatic NSCLC who have failed two or more previous chemotherapy regimens.
The Investigator plans to enroll 18 evaluable patients in Stage 1, and additionally up to 22 evaluable patients in Stage 2 for a total of 40 evaluable patients. Participants will be followed for overall survival. Current salvage therapy in advanced NSCLC achieves a median progression free survival time of 10 weeks and overall survival of 10 months. The Investigator would like to provide evidence that mifepristone will increase the median progression-free survival time to 15 weeks and overall survival time of 16 months.
Read the detailed description
This is a non-randomized, multicenter, single-stage phase II study of mifepristone in patients with Stage IIIB or Stage IV NSCLC who have failed two or more previous chemotherapy regimens.
The primary objective of this trial is to evaluate the utility of mifepristone as a salvage therapy in patients with Stage IIIB or Stage IV non-small cell lung carcinoma who have failed at least two previous chemotherapy regimens. Efficacy will be measured by improvement in progression-free survival and life span; and overall response as compared to historical controls.
Plan to enroll 18 evaluable patients in Stage 1 and up to 22 evaluable patients in Stage 2 for a total of 40 evaluable patients. Anticipated duration of the study is approximately up to 36 months.
Patients who tolerate treatment in the first cycle are eligible to continue to receive treatment until they experience unacceptable toxicity, until they meet any of the withdrawal criteria, or until the study is terminated by the Sponsor.
Patient may continue treatment despite evidence of tumor progression if they feel better, i.e. improved quality of life.We will follow all patients for overall survival.
Current salvage therapy in advanced NSCLC achieves a median progression free survival time of 10 weeks and overall survival of 10 months. We would like to provide evidence that mifepristone will increase the median progression-free survival time to 15 weeks and overall survival time of 16 months.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- Mifepristone
- 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.
MifepristoneDrug
Also called KORLYM®, C1073, CORLUXIN™ and CORLUX™.
Mifepristone is an antagonist of the GR-II (glucocorticoid) receptor, yet has little affinity for the GR-I (mineralocorticoid) receptor. Mifepristone is also a potent antagonist at the progesterone receptor, and may block the androgen receptor to a limited degree.
| Study group | Role | What they receive |
|---|---|---|
| mifepristone | Experimental | mifepristone 300 mg capsule per day, orally in 28-day cycles Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
defined as the time from first dose of study drug to the date of death
Measured: through study completion, an average of 16 months
A. Improvement in Quality of Life (QoL)
Participants complete QoL questionnaire EROTC QLQ-C30 every 8 weeks
Measured: every 8 weeks from date of enrollment until end of study or the date of death from any cause, assessed using QoL questionnaire,assessed up to 56 months.
B. Improvement in Quality of Life (QoL)
Participants complete QoL questionnaire EROTC QLQ-LC13 (specific to lung cancer)
Measured: every 8 weeks from date of enrollment until end of study or the date of death from any cause, assessed using QoL questionnaire,assessed up to 56 months.
Secondary outcomes (3)
Progression free survival
defined as the time from first dose of study drug to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause
Measured: median of 15 weeks from study enrollment until end of study or the date of first documented progression, assessed every 12 weeks by radiologic examination,assessed up to 56 months.
Overall response rate
defined as the number of subjects whose best confirmed objective response is either a complete response (CR) or partial response (PR) divided by the number of randomized subjects
Measured: assessed every 4 weeks, from date of enrollment until end of study or the date of death from any cause, assessed up to 56 months.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
to determine any toxicity from the drug at the 300 mg dosage.
Measured: assessed every week for 1 month and then every 4 weeks, from date of enrollment until end of study or the date of death from any cause, assessed up to 56 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Check, Jerome H., M.D., Ph.D.
- Collaborators
- Corcept Therapeutics
- Responsible party
- Sponsor
- Investigators
- Jerome H Check, MD,PhD, Principal investigator, Cooper Institute for Reproductive Hormonal Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642939
- Sponsor's protocol ID
- MIF-01-2014
- Status last verified
- Oct 2020
- First submitted
- 11 Dec 2015
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: See below
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Treatment With Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Two or More Previous Chemotherapy Regimens
- ClinicalTrials.gov ID
- NCT02642939
- Acronym / sponsor ID
- MIF-01-2014
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Check, Jerome H., M.D., Ph.D.
- Collaborators
- Corcept Therapeutics
- Study start
- Dec 2015 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized, multicenter, single-stage phase II study of mifepristone in patients with advanced or metastatic NSCLC who have failed two or more previous chemotherapy regimens.
The Investigator plans to enroll 18 evaluable patients in Stage 1, and additionally up to 22 evaluable patients in Stage 2 for a total of 40 evaluable patients. Participants will be followed for overall survival. Current salvage therapy in advanced NSCLC achieves a median progression free survival time of 10 weeks and overall survival of 10 months. The Investigator would like to provide evidence that mifepristone will increase the median progression-free survival time to 15 weeks and overall survival time of 16 months.
Detailed description
This is a non-randomized, multicenter, single-stage phase II study of mifepristone in patients with Stage IIIB or Stage IV NSCLC who have failed two or more previous chemotherapy regimens.
The primary objective of this trial is to evaluate the utility of mifepristone as a salvage therapy in patients with Stage IIIB or Stage IV non-small cell lung carcinoma who have failed at least two previous chemotherapy regimens. Efficacy will be measured by improvement in progression-free survival and life span; and overall response as compared to historical controls.
Plan to enroll 18 evaluable patients in Stage 1 and up to 22 evaluable patients in Stage 2 for a total of 40 evaluable patients. Anticipated duration of the study is approximately up to 36 months.
Patients who tolerate treatment in the first cycle are eligible to continue to receive treatment until they experience unacceptable toxicity, until they meet any of the withdrawal criteria, or until the study is terminated by the Sponsor.
Patient may continue treatment despite evidence of tumor progression if they feel better, i.e. improved quality of life.We will follow all patients for overall survival.
Current salvage therapy in advanced NSCLC achieves a median progression free survival time of 10 weeks and overall survival of 10 months. We would like to provide evidence that mifepristone will increase the median progression-free survival time to 15 weeks and overall survival time of 16 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mifepristone | Experimental | Drug: Mifepristonemifepristone 300 mg capsule per day, orally in 28-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Each patient must meet the following criteria to be enrolled in the study
- Must understand and voluntarily sign an informed consent
- Age ≥ 18 years at the time of signing the informed consent
- Histological or cytological documented diagnosis of locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC
- Patients must have evidence of disease, measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Key exclusion criteria (19 listed)
- Pregnant or breast-feeding
- Women with a history of unexplained vaginal bleeding.
- Women with uterine hyperplasia - in pre-menopausal women hyperplasia >18mm and in post-menopausal women hyperplasia of >10mm Prior therapy with mifepristone
- Prior therapy with mifepristone
- Patients who have had recent systemic cytotoxic therapies or radiotherapy within 14 days prior to day 1 of cycle 1
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 |
|---|---|---|
| MifepristoneAlso: KORLYM®, C1073, CORLUXIN™ and CORLUX™.Mifepristone is an antagonist of the GR-II (glucocorticoid) receptor, yet has little affinity for the GR-I (mineralocorticoid) receptor. Mifepristone is also a potent antagonist at the progesterone receptor, and may block the androgen receptor to a limited degree. | Drug | mifepristone |
Primary outcome
Overall Survival
Time frame: through study completion, an average of 16 months
defined as the time from first dose of study drug to the date of death
A. Improvement in Quality of Life (QoL)
Time frame: every 8 weeks from date of enrollment until end of study or the date of death from any cause, assessed using QoL questionnaire,assessed up to 56 months.
Participants complete QoL questionnaire EROTC QLQ-C30 every 8 weeks
B. Improvement in Quality of Life (QoL)
Time frame: every 8 weeks from date of enrollment until end of study or the date of death from any cause, assessed using QoL questionnaire,assessed up to 56 months.
Participants complete QoL questionnaire EROTC QLQ-LC13 (specific to lung cancer)
3 secondary outcomes
Progression free survival
Time frame: median of 15 weeks from study enrollment until end of study or the date of first documented progression, assessed every 12 weeks by radiologic examination,assessed up to 56 months.
Overall response rate
Time frame: assessed every 4 weeks, from date of enrollment until end of study or the date of death from any cause, assessed up to 56 months.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: assessed every week for 1 month and then every 4 weeks, from date of enrollment until end of study or the date of death from any cause, assessed up to 56 months.
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Yes. See below
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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.
Jerome H Check, MD,PhD principal investigator
Cooper Institute for Reproductive Hormonal Disorders
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 Mifepristone in people with Non-Small Cell Lung Cancer (NSCLC), run by Check, Jerome H., M.D., Ph.D. 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 22 inclusion and 19 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 19 Oct 2020. 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?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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?
Overall Survival (time frame: through study completion, an average of 16 months). The study lists 3 primary outcomes in all. 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 19 Oct 2020.