Clinical Trials /

Virexxa (Sodium Cridanimod) w/Progestin Therapy in Pts w/Progesterone Receptor Neg Recurrent/Persistent Endometrial CA

NCT02064725

Description:

This is an open label, multi-center, single arm phase II study. The study will investigate the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of patients with recurrent or persistent PrR-negative endometrial cancer.

Related Conditions:
  • Endometrial Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Virexxa</span> (<span class="go-doc-concept go-doc-intervention">Sodium Cridanimod</span>) w/<span class="go-doc-concept go-doc-intervention">Progestin</span> Therapy in Pts w/<span class="go-doc-concept go-doc-intervention">Progesterone</span> Receptor Neg Recurrent/Persistent Endometrial CA

Title

  • Brief Title: Virexxa (Sodium Cridanimod) w/Progestin Therapy in Pts w/Progesterone Receptor Neg Recurrent/Persistent Endometrial CA
  • Official Title: A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
  • Clinical Trial IDs

    NCT ID: NCT02064725

    ORG ID: VX-EC-2-2013

    Trial Conditions

    Recurrent or Persistent Endometrial Carcinoma

    Trial Interventions

    Drug Synonyms Arms
    Sodium cridanimod Virexxa Sodium cridanimod

    Trial Purpose

    This is an open label, multi-center, single arm phase II study. The study will investigate
    the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of
    patients with recurrent or persistent PrR-negative endometrial cancer.

    Detailed Description

    This is an open label, multi-center, single arm phase II study. The study will investigate
    the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of
    patients with recurrent or persistent PrR-negative endometrial cancer.

    Eligible patients will be enrolled into the study and administered sodium cridanimod in
    combination progestin therapy. Objective responses will be assessed at 12 week intervals.
    Patients will be treated for a 12 month period, followed by an additional 12 month follow up
    period or to disease progression whichever occurs first.

    Important objectives of the study are to investigate the effect of sodium cridanimod in
    conjunction with progestin therapy on the level of PrR in tumor tissue and how this
    correlates to efficacy. To accomplish this objective, some of the patients enrolled in the
    study will undergo two tumor biopsies that will allow measurement of PrR levels in the tumor
    tissue before the treatment and after 4 weeks of therapy.

    Trial Arms

    Name Type Description Interventions
    Sodium cridanimod Experimental Sodium cridanimod in combination with megestrol acetate or medroxyprogesterone acetate. Treatment period is 12 months; patients will be followed for another 12 month period or to disease progression whichever occurs first. Sodium cridanimod

    Eligibility Criteria

    Inclusion Criteria:

    - Female patients age 18 and older;

    - Histologically confirmed papillary serous adenocarcinoma or endometrioid type of
    endometrial carcinoma (histological documentation of recurrence is not required);

    - Patient has documented evidence of PrR negative endometrial cancer. PrR negativity
    can be determined by immunohistochemistry. The tumor is considered PrR negative if
    the number of PrR positive cells is less than 1% determined by immunohistochemistry;

    - Availability of tumor tissue sample that can be used for assessment of PrR levels
    with the use of immunohistochemistry;

    - Recurrent or persistent (after the failure of chemotherapy) disease that cannot be
    treated with surgery or radiotherapy;

    - Documented disease progression after a platinum based chemotherapy in patients for
    whom administration of taxanes and anthracyclines is not planned. Progression must
    fulfill one of the following criteria:

    - Progression has occurred within 30 days of platinum based chemotherapy
    consisting of minimum of two cycles of cisplatin-based (60 mg/m2/cycle) or
    carboplatin-based (300 mg/m2/cycle, or area under the time-concentration curve
    4) chemotherapy.

    - Progression after neoadjuvant or adjuvant platinum based chemotherapy if the
    recurrence occurred while on neoadjuvant/adjuvant chemotherapy or within 6
    months since the last administration of such therapy.

    - Measurable disease as defined by RECIST 1.1 criteria;

    - At least one "target lesion" to be used to assess response, as defined by RECIST 1.1
    criteria;

    - Tumors within a previously irradiated field will be designated as "non-target"
    lesions unless progression is documented;

    - GOG performance status 0-2;

    - Glomerular filtration rate 50 mL/min;

    - Total bilirubin normal;

    - AST 2.5 times upper limit of normal (ULN) ( 5 times ULN for patients with liver
    metastases);

    - Alkaline phosphatase 2.5 times ULN ( 5 times ULN for patients with liver
    metastases);

    - Albumin 3.0 mg/dL;

    - Ability to take oral medication;

    - Ability to understand and the willingness to sign a written informed consent
    document.

    Exclusion Criteria:

    - Evidence of histology of the tumor other than papillary serous adenocarcinoma or
    endometrioid type of endometrial carcinoma or mixed histology of the tumor;

    - History of hormonal therapy for endometrial carcinoma for more than 3 months;

    - History of use of progestins for a period of longer than 3 months for any indication,
    including endometriosis;

    - Concurrent maintenance corticosteroids;

    - Concurrent oral contraceptives/ Fertile patients must use effective barrier
    contraception;

    - Pregnancy as determined by pregnancy test or nursing;

    - History of bleeding (i.e. disseminated intravascular coagulation or clotting factor
    deficiency);

    - Prior major surgery less than 4 weeks prior to the start of the study;

    - Concurrent serious illness which, in the opinion of the investigator, would place the
    patient at unreasonable risk from study therapy;

    - Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix,
    basal cell carcinoma or squamous carcinoma of the skin;

    - History of allergic reactions or idiosyncrasy attributed to progestins or compounds
    of similar chemical structure to sodium cridanimod or lidocaine;

    - Known brain metastases;

    - Other concurrent investigational agents;

    - Other concurrent anticancer therapies.

    - Known carrier of HIV.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Objective Response Rate

    Secondary Outcome Measures

    Progression-free survival

    Time to response

    Time to progression

    Overall survival

    Overall Disease Control Rate

    Trial Keywords

    Endometrial cancer

    Recurrent or persistent endometrial carcinoma

    Progesterone Receptor Negative

    Sodium cridanimod

    Virexxa