Clinical Trials /

A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.

NCT02576548

Description:

This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.

Related Conditions:
  • Breast Carcinoma
  • Gastric Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

A Phase 1 Study of MEDI4276 in Adults Subjects With Select <span class="go-doc-concept go-doc-biomarker">HER2</span>-expressing Advanced Solid Tumors.

Title

  • Brief Title: A Phase 1 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.
  • Official Title: A Phase I Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogencity, and Antitumor Activity of MEDI4276 in Subjects With Select HER2-expressing Advanced Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT02576548

    ORG ID: D5760C00001

    Trial Conditions

    HER2 Expressing Breast or Gastric (Stomach) Cancers.

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This research study is designed to evaluate an experimental drug, MEDI4276, in treating
    breast and stomach (gastric) cancer.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm 1 Experimental MEDI 4276

    Eligibility Criteria

    Inclusion Criteria:

    1. 18 years

    2. Histologically or cytologically documented unresectable, locally advanced or
    metastatic breast cancer or gastric cancer refractory to standard therapy or for
    which no standard therapy exists

    3. HER2 Positive disease documented as in situ hybridization (ISH)-positive and or 3+ by
    IHC on previously collected tumor tissue.

    4. Subjects with primary tumor that is hormone (estrogen, progesterone or both) receptor
    positive or receptor negative are eligible

    5. Prior hormone therapy is allowed, but last dose must be at least 14 days prior to
    first dose of MEDI4276.

    Exclusion Criteria:

    1. Receipt of any conventional or investigational anticancer treatment within 28 days
    prior to the first dose of MEDI4276.

    2. History of Congestive Heart Failure

    3. History of exposure to the following cumulative doses of anthracyclines:

    1. Doxorubicin or liposomal doxorubicin >500 mg/m

    2. Epirubicin >900mg/m

    3. Mitoxantrone >120 mg/m and idarubicin > 90mg/m

    4. If another anthracycline or more than 1 anthracycline has been used, then the
    cumulative dose must not exceed the equivalent of 500mg/m of doxorubicin

    4. Known brain metastases that are untreated, symptomatic, or require therapy to control
    symptoms; or any radiation, surgery or other therapy to control symptoms from brain
    metastases within 2 months prior to first dose of MEDI4276.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 99 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs) and dose-limiting (DLTs).

    Secondary Outcome Measures

    Objective Response Rate (ORR)

    Peak Plasma Concentration (Cmax)

    Progression-free survival (PFS)

    Overall survival (OS)

    Area under the plasma concentration versus time curve (AUC)

    Trial Keywords