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

Recurrent or Persistent Endometrial Carcinoma Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02064725
• Other study ID #: VX-EC-2-2013
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 14, 2014
• Last updated: January 23, 2017
• Start date: September 2014
• Est. completion date: July 2018

Study information

• Verified date: January 2017
• Source: Kevelt AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Neoplasms
• Recurrent or Persistent Endometrial Carcinoma

Intervention

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).

Locations

Country	Name	City	State
Belarus	Brest Regional Clinical Hospital	Brest
Belarus	Minsk City Clinical Oncology Dispensary	Minsk
Belarus	N.N. Alexandrov National Cancer Centre of Belarus	Minsk
Belarus	Vitebsk Regional Clinical Oncology Dispensary	Vitebsk
Czech Republic	Masaryk Memorial Cancer Institute	Brno
Czech Republic	University Hospital Hradec Kralove	Hradec Kralove
Czech Republic	University Hospital Olomouc, Oncology	Olomouc
Slovakia	Oncology Institute of Saint Alzbeta	Bratislava
Slovakia	Poko Poprad, s.r.o.	Poprad
Slovakia	University Hospital Trencin	Trencin
Ukraine	Cherkasy Regional Oncology Dispensary	Cherkasy
Ukraine	Municipal Institution of Dnipropetrovsk Regional Rada	Dnipropetrovsk
Ukraine	Kharkiv Regional Clinical Oncology Center	Kharkiv
Ukraine	S.P. Grigoryeva Institute of Medical Radiology	Kharkiv
Ukraine	Kherson Regional Oncological Dispensary	Kherson
Ukraine	Sumy State University	Sumy
Ukraine	Vinnitsa Regional Clinical Oncology Center	Vinnitsa
United States	Montefiore Medical Center	Bronx	New York
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Physicians Research Group	San Jose	California
United States	St. Jude Hospital Yorba Linda, St. Joseph's Heritage Healthcare	Santa Rosa	California

Sponsors (2)

Lead Sponsor	Collaborator
Kevelt AS	Pharmasyntez

Countries where clinical trial is conducted

United States,  Belarus,  Czech Republic,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progesterone receptor (PrR) levels		1 months
Primary	Objective Response Rate		12 months
Secondary	Progression-free survival		24 months
Secondary	Time to response		12 months
Secondary	Time to progression		24 months
Secondary	Overall survival		24 months
Secondary	Overall Disease Control Rate		24 months