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

NCT02014337 | Completed Phase 1

• 1 other identifier: C1073-500
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 11

Brief 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 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

Conditions

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

Keywords

Mifepristone; Eribulin Mesylate; Breast Cancer; Ovarian Cancer; Sarcoma; Non-small cell lung cancer; Carcinoma, transitional cell; Prostate cancer; Prostatic neoplasms

Outcome Measures

Primary Outcomes (1)

• 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)

  28 days

Study Arms (1)

Mifepristone and Eribulin in combination

EXPERIMENTAL

Single Arm

Drug: Mifepristone and Eribulin in combination

Interventions

Mifepristone and Eribulin in combination DRUG

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

Also known as: Korlym®, Halaven

Mifepristone and Eribulin in combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (11)

ACRC/Arizona Clinical Research Center Inc.

Tucson, Arizona, 85715, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30308, United States

Location

Rita Nanda, MD

Chicago, Illinois, 60637, United States

Location

Quest Research

Royal Oaks, Michigan, 48073, United States

Location

St. Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Sarcoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Prostatic Neoplasms; Ovarian Neoplasms

Interventions

Mifepristone; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Rita Nanda, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 18, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)