NCT02064725

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2014

Typical duration for phase_2

Geographic Reach
5 countries

21 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

3.3 years

First QC Date

February 14, 2014

Last Update Submit

January 23, 2017

Conditions

Recurrent or Persistent Endometrial Carcinoma

Keywords

Endometrial cancerRecurrent or persistent endometrial carcinomaProgesterone Receptor NegativeSodium cridanimodVirexxa

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    12 months

Secondary Outcomes (5)

  • Progression-free survival

    24 months

  • Time to response

    12 months

  • Time to progression

    24 months

  • Overall survival

    24 months

  • Overall Disease Control Rate

    24 months

Other Outcomes (1)

  • Progesterone receptor (PrR) levels

    1 months

Study Arms (1)

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.

Drug: Sodium cridanimod

Interventions

Sodium cridanimodDRUG

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).

Also known as: Virexxa
Sodium cridanimod

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • +4 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Physicians Research Group

San Jose, California, 95124, United States

Location

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

Santa Rosa, California, 95403, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Brest Regional Clinical Hospital

Brest, Belarus

Location

Minsk City Clinical Oncology Dispensary

Minsk, Belarus

Location

N.N. Alexandrov National Cancer Centre of Belarus

Minsk, Belarus

Location

Vitebsk Regional Clinical Oncology Dispensary

Vitebsk, Belarus

Location

Masaryk Memorial Cancer Institute

Brno, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, Czechia

Location

University Hospital Olomouc, Oncology

Olomouc, Czechia

Location

Oncology Institute of Saint Alzbeta

Bratislava, Slovakia

Location

Poko Poprad, s.r.o.

Poprad, Slovakia

Location

University Hospital Trencin

Trenčín, Slovakia

Location

Cherkasy Regional Oncology Dispensary

Cherkasy, Ukraine

Location

Municipal Institution of Dnipropetrovsk Regional Rada

Dnipropetrovsk, Ukraine

Location

Kharkiv Regional Clinical Oncology Center

Kharkiv, Ukraine

Location

S.P. Grigoryeva Institute of Medical Radiology

Kharkiv, Ukraine

Location

Kherson Regional Oncological Dispensary

Kherson, Ukraine

Location

Sumy State University

Sumy, Ukraine

Location

Vinnitsa Regional Clinical Oncology Center

Vinnitsa, Ukraine

Location

MeSH Terms

Conditions

RecurrenceEndometrial Neoplasms

Interventions

10-carboxymethyl-9-acridanone

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Laura L. Douglass

    Kevelt AS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2018

Study Completion

July 1, 2018

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

UA(7)US(4)CZ(3)BE(4)SL(3)