Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02064725
Recruitment Status : Unknown
Verified January 2017 by Kevelt AS.
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
Pharmasyntez
Information provided by (Responsible Party):
Kevelt AS

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 17, 2014
Last Update Posted Date January 24, 2017
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
Objective Response Rate [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02064725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • Progression-free survival [ Time Frame: 24 months ]
  • Time to response [ Time Frame: 12 months ]
  • Time to progression [ Time Frame: 24 months ]
  • Overall survival [ Time Frame: 24 months ]
  • Overall Disease Control Rate [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 14, 2014)
Progesterone receptor (PrR) levels [ Time Frame: 1 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Virexxa (Sodium Cridanimod) w/Progestin Therapy in Pts w/Progesterone Receptor Neg Recurrent/Persistent Endometrial CA
Official Title  ICMJE A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent or Persistent Endometrial Carcinoma
Intervention  ICMJE Drug: Sodium cridanimod
Eligible patients will be enrolled into the study and administered sodium cridanimod (500 mg i.m./ twice a week) in combination with megestrol acetate (160 mg p.o./ day) or medroxyprogesterone acetate (200 mg p.o./ day).
Other Name: Virexxa
Study Arms  ICMJE Experimental: Sodium cridanimod
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.
Intervention: Drug: Sodium cridanimod
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 23, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2014)
58
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Czech Republic,   Slovakia,   Ukraine,   United States
Removed Location Countries Canada,   Estonia,   Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT02064725
Other Study ID Numbers  ICMJE VX-EC-2-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kevelt AS
Study Sponsor  ICMJE Kevelt AS
Collaborators  ICMJE Pharmasyntez
Investigators  ICMJE
Study Director: Laura L. Douglass Kevelt AS
PRS Account Kevelt AS
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP