Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors

Completed · Phase 1

Conditions studied: Breast Cancer, Ovarian Epithelial Cancer Recurrent, Sarcoma, Non-small Cell Lung Cancer, Carcinoma, Transitional Cell, Prostate Cancer, Prostatic Neoplasms

In brief

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

Key facts

Study ID: NCT02014337
Run by: Corcept Therapeutics
People needed: 37
Starts: 2014-01-01
Expected to finish: 2017-12-01
Last updated by the study team: 2018-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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):
i. ANC ≥ 1,500/mm3, without G-CSF
ii. Platelets ≥ 100,000/mm3, without transfusion
iii. Hemoglobin ≥ 9 g/dL, without transfusion support
iv. AST or ALT ≤ 3 × ULN
v. Total serum bilirubin ≤ 1.5 times ULN
vi. Serum creatinine ≤ ULN
vii. 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.
viii. 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

You may not qualify if…

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
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

Where it is running

ACRC/Arizona Clinical Research Center Inc. — Tucson, Arizona, United States
H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
Rita Nanda, MD — Chicago, Illinois, United States
Quest Research — Royal Oaks, Michigan, United States
St. Luke's Cancer Institute — Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
Cancer Care Centers of South Texas — San Antonio, Texas, United States
Texas Oncology - Tyler — Tyler, Texas, United States
Virginia Cancer Specialists — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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