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

NCT ID: NCT02064725

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-07-31

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.

Conditions

Recurrent or Persistent Endometrial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sodium cridanimod

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Virexxa

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
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pharmasyntez

INDUSTRY

Sponsor Role: collaborator

Kevelt AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura L. Douglass

Role: STUDY_DIRECTOR

Kevelt AS

Locations

Physicians Research Group

San Jose, California, United States

St. Jude Hospital Yorba Linda, St. Joseph's Heritage Healthcare

Santa Rosa, California, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Montefiore Medical Center

The Bronx, New York, United States

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, , Belarus

Masaryk Memorial Cancer Institute

Brno, , Czechia

University Hospital Hradec Kralove

Hradec Králové, , Czechia

University Hospital Olomouc, Oncology

Olomouc, , Czechia

Oncology Institute of Saint Alzbeta

Bratislava, , Slovakia

Poko Poprad, s.r.o.

Poprad, , Slovakia

University Hospital Trencin

Trenčín, , Slovakia

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, , Ukraine

Countries

United States; Belarus; Czechia; Slovakia; Ukraine

Other Identifiers

VX-EC-2-2013

Identifier Type: -

Identifier Source: org_study_id