Breast CancerPhase 1NCT02014337
Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors
A Phase 1 study testing Mifepristone and Eribulin in combination in people with Breast Cancer and Ovarian Epithelial Cancer Recurrent, run by Corcept Therapeutics at 11 sites in United States.
Trial summary
This is a study to assess the safety of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable breast or other specified solid tumors, and determine preliminary efficacy of the combination of mifepristone and eribulin in patients with metastatic or locally advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ovarian Epithelial Cancer Recurrent, Sarcoma
- What is being tested?
- Mifepristone and Eribulin in combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2014to Dec 2017
- Phase
- Phase 1
- 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
- Informed consent given prior to study-specific screening procedures
- ≥ 18 years old
- Part 2, dose expansion:
- Diagnosis of TNBC: < 1% cells positive for ER/progesterone receptor, and HER2 IHC score of 0 or 1, or FISH HER2+ ratio of less than 1.8; patients with low ER IHC (> 1% but < 10% cells positive), but negative by genomic assay are eligible
- Inoperable metastatic or locally advanced unresectable disease
- Patients should have received a minimum of one, and up to five prior chemotherapy regimens
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- Must have submitted a diagnostic FFPE tumor tissue sample to confirm tumor GR positivity. Tumor tissue may be from primary or metastatic lesion. In the absence of sufficient tissue to complete IHC, a tumor biopsy will be required.
- Tumor must be glucocorticoid receptor positive TNBC (≥10% positive cells by IHC of tumor biopsy)
- Must have measurable disease (RECIST v1.1) in at least one lesion not previously irradiated unless documented evidence of progression
- Patients with treated, stable brain metastases eligible providing treatment was ≥4 weeks prior to initiation of study drug, and baseline CT or MRI negative for new brain metastases. Must not require therapy with corticosteroids.
- ECOG performance status 0 or 1
- Must have adequate bone marrow and renal/hepatic function at the screening visit (≤7 days preceding the lab assessment):
- ANC ≥ 1,500/mm3, without G-CSF
- Platelets ≥ 100,000/mm3, without transfusion
- Hemoglobin ≥ 9 g/dL, without transfusion support
- AST or ALT ≤ 3 × ULN
- Total serum bilirubin ≤ 1.5 times ULN
- Serum creatinine ≤ ULN
- Potassium and magnesium levels within normal limits. If below the lower limit of normal, must have levels corrected by supplementation prior to starting study drug.
- albumin > 3.0 g/dL
- PT/aPIT ≤ 1.5 x ULN
- 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 patients of childbearing potential must have a negative serum pregnancy test. Sexually active patients must be willing to use non-hormonal contraception, including condom use by male partner, and barrier method by the female partner 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 > 2 years, or are surgically sterile (status post tubal ligation or hysterectomy).
- Must be able and willing to comply with the study visit schedule and study procedures.
- Able to take oral medications
Who cannot join
- Systemic cytotoxic therapies or radiotherapy ≤14 days prior to day 1 cycle 1
- Major surgery within 4 weeks, or minor surgery within 2 weeks prior to day 1 of cycle 1
- Endometrial bleeding
- For two weeks prior to day 1 cycle 1, administration of specified cytochrome P450 3A (CYP3A) inducers
- 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 <21 days prior to day 1 of cycle 1
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- Concomitant use of biological agents including growth factors. Exception: 3- to 6-patient breast cancer cohort enrolled to explore the use of prophylactic growth-factor support of a 1.4 mg/m2 dose of eribulin.
- Patients who require treatment with systemic corticosteroids for serious medical conditions or illnesses (e.g. immunosuppression after organ transplantation)
- History of significant cardiac disease. Includes second/third degree heart block; significant ischemic heart disease; mean QTc interval > 480 msec prior to study start; poorly controlled hypertension; congestive heart failure of NYHA Class II or worse
- Pregnant or breast-feeding
- Any other significant co-morbid conditions that would impair study participation or cooperation
- In Part 2, unable or unwilling to consent to provision of tumor tissue for GR assay
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30308
Rita Nanda, MD
Chicago, Illinois, 60637
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Virginia Cancer Specialists
Fairfax, Virginia, 22031
St. Luke's Cancer Institute
Kansas City, Missouri, 64111
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Quest Research
Royal Oaks, Michigan, 48073
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
ACRC/Arizona Clinical Research Center Inc.
Tucson, Arizona, 85715
Texas Oncology - Tyler
Tyler, Texas, 75702
About this study
Official title: Phase 1 Study of Mifepristone in Combination With Eribulin in Patients With Locally Advanced/Metastatic Breast or Other Specified Solid Tumors, With a Dose Expansion Cohort in Patients With Triple Negative Breast Cancer.
This is a study to assess the safety of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable breast or other specified solid tumors, and determine preliminary efficacy of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable Triple Negative Breast Cancer (TNBC). The structure for the study is a single arm, non-randomized, open-label, multicenter trial with no control group. The study will be conducted at up to 11 sites, with up to 40 evaluable patients
Read the detailed description
There will be two parts to the study: Part 1, a dose escalation phase, in which the MTD and RP2D will be determined in up to 20 patients with metastatic breast or other specified solid tumors, regardless of receptor status; and Part 2, a dose expansion phase in which a preliminary estimate of efficacy will be made in an expansion group of up to 20 patients with glucocorticoid receptor-positive metastatic TNBC at the RP2D.
Treatment will be administered in 21-day cycles, with the exception of the first cycle, which will be of 28 days duration with a lead-in of 7 days dosing of mifepristone.
Cycle 1 (28-day cycle): Mifepristone administered orally (PO) with food once daily for 28 days. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on days 8 and 15.
Cycle 2 and beyond (21-day cycle): Mifepristone administered orally (PO) with food once daily for 21 days. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on days 1 and 8.
Enrollment in Part 2 of the study (dose expansion) will occur once the RP2D has been determined. Patients in the dose expansion study must have TNBC disease that is glucocorticoid receptor-positive (by immunohistochemistry [IHC]). Patients will be treated in repeated 21-day cycles until progression or another withdrawal criterion is met.
Part 1 of the study is complete. Part 2 of the study is ongoing.
- Conditions
- Breast Cancer, Ovarian Epithelial Cancer Recurrent, Sarcoma, Non-small Cell Lung Cancer, Carcinoma, Transitional Cell, Prostate Cancer
- Being tested
- Mifepristone and Eribulin in combination
- Keywords
- Mifepristone, Eribulin Mesylate, Breast Cancer, Ovarian Cancer, Sarcoma, Non-small cell lung cancer, Carcinoma, transitional cell, Prostate cancer, Prostatic neoplasms
- Medical subject headings
- Breast Neoplasms, Sarcoma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Transitional Cell, Prostatic Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone and Eribulin in combinationDrug
Also called Korlym®, Halaven
Single Arm, Two Parts Part 1: Dose Escalation Phase to determine MTD and RP2D in up to 20 patients Part 2: Dose Expansion Phase at RP2D in 20 patients
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone and Eribulin in combination | Experimental | Single Arm Receives: Drug: Mifepristone and Eribulin in combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable breast or other specified solid tumors.
In the dose escalation phase: MTD time frame is within 28 days of first dose (Cycle 1)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rita Nanda, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014337
- Sponsor's protocol ID
- C1073-500
- Status last verified
- Jan 2018
- First submitted
- 4 Dec 2013
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Mifepristone in Combination With Eribulin in Patients With Locally Advanced/Metastatic Breast or Other Specified Solid Tumors, With a Dose Expansion Cohort in Patients With Triple Negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT02014337
- Acronym / sponsor ID
- C1073-500
- Conditions
- Breast Cancer, Ovarian Epithelial Cancer Recurrent, Sarcoma, Non-small Cell Lung Cancer, Carcinoma, Transitional Cell, Prostate Cancer
- Keywords
- Mifepristone, Eribulin Mesylate, Breast Cancer, Ovarian Cancer, Sarcoma, Non-small cell lung cancer, Carcinoma, transitional cell, Prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Dec 2013 (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 study to assess the safety of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable breast or other specified solid tumors, and determine preliminary efficacy of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable Triple Negative Breast Cancer (TNBC). The structure for the study is a single arm, non-randomized, open-label, multicenter trial with no control group. The study will be conducted at up to 11 sites, with up to 40 evaluable patients
Detailed description
There will be two parts to the study: Part 1, a dose escalation phase, in which the MTD and RP2D will be determined in up to 20 patients with metastatic breast or other specified solid tumors, regardless of receptor status; and Part 2, a dose expansion phase in which a preliminary estimate of efficacy will be made in an expansion group of up to 20 patients with glucocorticoid receptor-positive metastatic TNBC at the RP2D.
Treatment will be administered in 21-day cycles, with the exception of the first cycle, which will be of 28 days duration with a lead-in of 7 days dosing of mifepristone.
Cycle 1 (28-day cycle): Mifepristone administered orally (PO) with food once daily for 28 days. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on days 8 and 15.
Cycle 2 and beyond (21-day cycle): Mifepristone administered orally (PO) with food once daily for 21 days. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on days 1 and 8.
Enrollment in Part 2 of the study (dose expansion) will occur once the RP2D has been determined. Patients in the dose expansion study must have TNBC disease that is glucocorticoid receptor-positive (by immunohistochemistry [IHC]). Patients will be treated in repeated 21-day cycles until progression or another withdrawal criterion is met.
Part 1 of the study is complete. Part 2 of the study is ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mifepristone and Eribulin in combination | Experimental | Drug: Mifepristone and Eribulin in combinationSingle Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Informed consent given prior to study-specific screening procedures
- ≥ 18 years old
- Diagnosis of TNBC: < 1% cells positive for ER/progesterone receptor, and HER2 IHC score of 0 or 1, or FISH HER2+ ratio of less than 1.8; patients with low ER IHC (> 1% but < 10% cells positive), but negative by genomic assay are eligible
- Inoperable metastatic or locally advanced unresectable disease
- Patients should have received a minimum of one, and up to five prior chemotherapy regimens
Key exclusion criteria (12 listed)
- Systemic cytotoxic therapies or radiotherapy ≤14 days prior to day 1 cycle 1
- Major surgery within 4 weeks, or minor surgery within 2 weeks prior to day 1 of cycle 1
- Endometrial bleeding
- For two weeks prior to day 1 cycle 1, administration of specified cytochrome P450 3A (CYP3A) inducers
- Patients who are taking simvastatin or lovastatin. Patients should be switched to alternative therapies a minimum of 2 weeks before starting study drug
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 |
|---|---|---|
| Mifepristone and Eribulin in combinationAlso: Korlym®, HalavenSingle Arm, Two Parts Part 1: Dose Escalation Phase to determine MTD and RP2D in up to 20 patients Part 2: Dose Expansion Phase at RP2D in 20 patients | Drug | Mifepristone and Eribulin in combination |
Primary outcome
Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable breast or other specified solid tumors.
Time frame: 28 days
In the dose escalation phase: MTD time frame is within 28 days of first dose (Cycle 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Rita Nanda, MD principal investigator
University of Chicago
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mifepristone and Eribulin in combination in people with Breast Cancer and Ovarian Epithelial Cancer Recurrent, run by Corcept Therapeutics at 11 sites 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 25 inclusion and 12 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: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable breast or other specified solid tumors. (time frame: 28 days). 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 17 Jan 2018.