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A Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

NCT02316509

Description:

This is an open-label, dose-finding, safety, pharmacokinetics (PK), and evidence-of-activity study of GDC-0927 in postmenopausal women with locally advanced or metastatic Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 (HER2) breast cancer. The study will be conducted in two parts: Dose escalation and Dose expansion. During dose escalation, GDC-0927 will be administered orally as a single dose on Day -7 for PK evaluation during the lead-in period. Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0927 using standard 3+3 design. During dose expansion, there will be no PK week lead-in period. All participants will be treated until disease progression, unacceptable toxicity, participant withdrawal of consent or study termination.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Study of <span class="go-doc-concept go-doc-intervention">SRN-927</span> in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Study of SRN-927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
  • Official Title: An Open-Label, Phase I Study of SRN-927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT02316509

    ORG ID: GO29656

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    SRN-927 SRN-927

    Trial Purpose

    This is an open-label, dose-finding study of SRN-927 administered orally on a continuous
    daily dosing regimen with a PK lead-in period (dose escalation period only). The incidence
    of dose limiting toxicity (DLT) will be evaluated from Day -7 through the first cycle (28
    days) of treatment (35 days total). Depending on safety and tolerability, patients will be
    assigned sequentially to escalating doses of SRN-927 using standard 3+3 design. All patients
    will be treated until disease progression, unacceptable toxicity, or patient withdrawal of
    consent.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    SRN-927 Experimental During dose escalation, a standard 3+3 design will be followed. During dose expansions, two new cohorts of patients will be enrolled at the MTD and/or recommended Phase II dose (RP2D) to further characterize the safety and pharmacokinetics of SRN-927. SRN-927

    Eligibility Criteria

    Inclusion Criteria:

    - Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with
    evidence of either locally recurrent disease not amenable to resection or radiation
    therapy with curative intent, or metastatic disease, both progressing after at least
    6 months of hormonal therapy for ER+ breast cancer

    - ER-positive, HER2-negative

    - No prior treatment with ARN-810 (allowed only during dose expansion stage)

    - No more than 2 prior chemotherapies in the advanced or metastatic setting

    - At least 2 months must have elapsed from the use of tamoxifen

    - At least 6 months must have elapsed from the use of fulvestrant

    - At least 2 weeks must have elapsed from the use of any other anti-cancer hormonal
    therapy

    - At least 3 weeks must have elapsed from the use of any chemotherapy

    - Females, 18 years of age or older

    - Postmenopausal status as defined by the protocol

    - Eastern Cooperative Oncology Group (ECOG) Performance status </= 2

    - Adequate organ function

    Exclusion Criteria:

    - Untreated or symptomatic brain metastases

    - Current treatment with any systemic anti-cancer therapies for advanced disease or any
    systemic experimental treatment on another clinical trial

    - Any of the following within 12 months prior to enrollment: myocardial infarction,
    severe/unstable angina, ongoing cardiac dysrhythmias of Grade >/= 2, atrial
    fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic
    congestive heart failure, or cerebrovascular accident including transient ischemic
    attack

    - Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper
    gastrointestinal surgery including gastric resection

    - Known human immunodeficiency virus infection

    - Major surgery within 4 weeks prior to enrollment

    - Radiation therapy within 2 weeks prior to enrollment

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Safety (composite outcome measure): Incidence of adverse events (AEs), serious adverse events (SAEs), non-serious AEs of special interest; measurement of safety laboratory assessments, vital signs and other protocol-specified safety parameters

    Maximum Tolerated Dose (MTD)

    Secondary Outcome Measures

    Pharmacokinetics (PK) profile analysis of SRN-927 in blood plasma (Cmax, Tmax, AUC, T1/2) [composite outcome measure]

    Trial Keywords