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Mifepristone and Eribulin in combination

Phase 1

Breast Cancer | Small molecule | Oncology |Corcept Therapeutics Incorporated|Last Updated: Jan 17, 2018

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

Mifepristone and Eribulin in combination · 1 trial · 7 indications

Phase 1 1
NCT02014337Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid TumorsBreast Cancer
COMPLETED37 Analytics
PHASE1COMPLETED
Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
28 days

In the dose escalation phase: MTD time frame is within 28 days of first dose (Cycle 1)

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Mifepristone and Eribulin in combinationEXPERIMENTALSingle Arm

Interventions

NameTypeDescription
Mifepristone and Eribulin in combinationDRUGSingle 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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Informed consent given prior to study-specific screening procedures 2. ≥ 18 years old Part 2, dose expansion: 1. 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 IH...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Mifepristone and Eribulin in combination

What is Mifepristone used for?

Mifepristone is being developed by Corcept Therapeutics for Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. It is a small molecule in Phase 3 clinical development for these endocrine and psychiatric conditions. The drug is investigational and has not been approved for these indications.

Who makes Mifepristone?

Corcept Therapeutics Incorporated (NASDAQ: CORT) is developing Mifepristone. The company is conducting clinical trials for the drug in indications including Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. Corcept Therapeutics is the developer of this investigational small molecule.

What phase is Mifepristone in?

Mifepristone is in Phase 3 clinical development for Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. The drug is investigational and has not been approved by regulatory authorities for these indications. Corcept Therapeutics is conducting the clinical development program.

What clinical trials has Mifepristone been in?

Mifepristone has completed five clinical trials. These include NCT00455442, a Phase 2 study in weight-gain prevention; NCT00698022, a Phase 1 study in healthy volunteers; NCT03258372 and NCT03259542, Phase 1 drug-drug interaction studies; and one additional completed trial. All trials are completed with no active studies ongoing.

How does Mifepristone work?

Mifepristone is a small molecule that acts as a glucocorticoid receptor antagonist. By blocking the glucocorticoid receptor, it is being studied for its effects in Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. This mechanism is relevant to conditions involving cortisol dysregulation.

Is Mifepristone the same as Korlym?

Mifepristone is the active ingredient in Korlym, a medication approved for Cushing's syndrome. However, the data provided does not specify whether the Mifepristone in development by Corcept Therapeutics is the same product as Korlym. The drug is being studied in Phase 3 trials for related indications.