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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent or Persistent Endometrial Carcinoma Drug: Sodium cridanimod Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018
Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 24 months ]
  2. Time to response [ Time Frame: 12 months ]
  3. Time to progression [ Time Frame: 24 months ]
  4. Overall survival [ Time Frame: 24 months ]
  5. Overall Disease Control Rate [ Time Frame: 24 months ]

Other Outcome Measures:
  1. Progesterone receptor (PrR) levels [ Time Frame: 1 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064725


Locations
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Sponsors and Collaborators
Kevelt AS
Pharmasyntez
Investigators
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Study Director: Laura L. Douglass Kevelt AS
More Information
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Responsible Party: Kevelt AS
ClinicalTrials.gov Identifier: NCT02064725    
Other Study ID Numbers: VX-EC-2-2013
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Keywords provided by Kevelt AS:
Endometrial cancer
Recurrent or persistent endometrial carcinoma
Progesterone Receptor Negative
Sodium cridanimod
Virexxa
Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
10-carboxymethyl-9-acridanone
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs