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Protocol No. UW17107

Principal Investigator ORegan, Ruth

Phase II

Age Group Adult

Scope Local

Sponsor Type Institutional

Title Phase 2 Study of ONC201 with and without Methionine-Restricted Diet in Patients with Metastatic Triple Negative Breast Cancer

Objective The purpose of this research study is to see what effect(s) the drug ONC201 will have on triple negative breast cancer when taken alone and when combined with a diet low in methionine. Triple negative breast cancer (TNBC) is a type of breast cancer that tests negative for estrogen receptors (ER-), progesterone receptors (PR-), and human epidermal growth factor receptor-2 (HER2-). Receptors are molecules that receive and respond to signals (such as hormones) from outside a cell. Testing negative for these receptors means that your cancer growth is not caused by the hormones estrogen or progesterone, or by having too many HER2 receptors. Most breast therapies target one of these receptors, so triple negative breast cancers can be more difficult to treat than other types of breast cancer.

Arm A: ONC201 alone
Arm B: ONC201 with a diet low in Methionine
  • ONC201, will be supplied in capsule form for oral dosing. ONC201 625 mg (5 tablets of 125 mg each) will be given by mouth once every week on both arms (Days 3, 10, and 17 each cycle). Treatment will be administered primarily on an outpatient basis, but can be administered as an inpatient. A cycle is equal to 21 days

  • Description Phase 2 study with ONC201 +/- Methionine Restriction Diet for metastatic triple negative breast cancer

    Key Eligibility
  • Metastatic or unresectable TNBC (ER less than 1%, PR less than 1% and HER2 negative either by IHC or in situ hybridization method by ASCO-CAP guidelines)
  • Measurable disease by RECIST 1.1
  • Females 18-64 years of age at the time of consent. Men are not eligible to participate
  • Any number of prior lines of systemic therapy for metastatic disease
  • ECOG PS of 0 or 1
  • Prior cancer treatment must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to less than or equal to grade 1 or to baseline prior to initiation of that therapy. Other than neuropathy, which must have resolved to less than grade 2
  • No active CNS metastatic disease; subjects with prior definitive treatment of their CNS disease by surgical resection, SBRT or WBRT greater than 28 days ago will be eligible if asymptomatic and off systemic steroids
  • Normal organ and marrow function as defined per protocol
  • Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), they are naturally postmenopausal for at least 12 consecutive months
  • Females of childbearing potential must be willing to abstain from heterosexual activity or must agree to use adequate contraception (hormonal or barrier method) for the duration of study participation and for 90 days after discontinuation of study treatment
  • Able to swallow ONC201
  • No prior therapy with TRAIL receptor agonists
  • Active infection requiring systemic therapy. Patients with a known history of HIV must have a CD4 count greater than or equal to the institutional lower limit of normal within 28 days prior to registration. Patients with HIV must also be on a stable antiretroviral regimen for greater than or equal to 28 days before registration
  • Pregnant or breastfeeding
  • Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patients who follow a vegan or vegetarian diet

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics