NCT02014337

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.

Completed Phase 1 Last updated 12 January 2018

What this trial tests

Phase 1 trial testing Mifepristone and Eribulin in combination in Breast Cancer in 37 participants. Completed in 1 December 2017.

Timeline

1 January 2014

Primary endpoint
1 December 2017

1 December 2017

Quick facts

Lead sponsor	Corcept Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	1 January 2014
Primary completion	1 December 2017
Estimated completion	1 December 2017
Sites	11 locations across United States

Drugs / interventions tested

• Mifepristone and Eribulin in combination — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Ovarian Epithelial Cancer Recurrent — all drugs for Ovarian Epithelial Cancer Recurrent →
• Sarcoma — all drugs for Sarcoma →
• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Corcept Therapeutics — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Ovarian Epithelial Cancer Recurrent. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Review of Systemic Treatment in Metastatic Triple-Negative Breast Cancer.
   Zeichner SB, Terawaki H, Gogineni K. · · 2016 · cited 134× · PMID 27042088 · DOI 10.4137/bcbcr.s32783
2. Eribulin in Cancer Treatment.
   Swami U, Shah U, Goel S. · · 2015 · cited 46× · PMID 26262627 · DOI 10.3390/md13085016
3. The Role of Steroid Hormones in Breast and Effects on Cancer Stem Cells.
   Alferez DG, Simões BM, Howell SJ, Clarke RB. · · 2018 · cited 30× · PMID 29600163 · DOI 10.1007/s40778-018-0114-z
4. Prognostic Significance of Glucocorticoid Receptor Expression in Cancer: A Systematic Review and Meta-Analysis.
   Bakour N, Moriarty F, Moore G, Robson T, et al · · 2021 · cited 28× · PMID 33916028 · DOI 10.3390/cancers13071649
5. Molecular mechanisms underlying mifepristone's agonistic action on ovarian cancer progression.
   Ponikwicka-Tyszko D, Chrusciel M, Stelmaszewska J, Bernaczyk P, et al · · 2019 · cited 25× · PMID 31466918 · DOI 10.1016/j.ebiom.2019.08.035
6. Antiprogestins in gynecological diseases.
   Goyeneche AA, Telleria CM. · · 2015 · cited 20× · PMID 25252652 · DOI 10.1530/rep-14-0416
7. Mechanisms behind context-dependent role of glucocorticoids in breast cancer progression.
   Butz H, Patócs A. · · 2022 · cited 17× · PMID 35761157 · DOI 10.1007/s10555-022-10047-1
8. Repurposing of drugs for triple negative breast cancer: an overview.
   Spini A, Donnini S, Pantziarka P, Crispino S, et al · · 2020 · cited 13× · PMID 32728387 · DOI 10.3332/ecancer.2020.1071