Recurrent or Persistent Endometrial CarcinomaPhase 2NCT02064725
Virexxa (Sodium Cridanimod) w/Progestin Therapy in Pts w/Progesterone Receptor Neg Recurrent/Persistent Endometrial CA
A Phase 2 study testing Sodium cridanimod in people with Recurrent or Persistent Endometrial Carcinoma, run by Kevelt AS at 21 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent or Persistent Endometrial Carcinoma
- What is being tested?
- Sodium cridanimod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 21 sitesin 5 countries
- Study dates
- Sep 2014to Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
Ukraine7 sites
Cherkasy Regional Oncology Dispensary
Cherkasy
Municipal Institution of Dnipropetrovsk Regional Rada
Dnipropetrovsk
Kharkiv Regional Clinical Oncology Center
Kharkiv
S.P. Grigoryeva Institute of Medical Radiology
Kharkiv
Kherson Regional Oncological Dispensary
Kherson
Sumy State University
Sumy
Vinnitsa Regional Clinical Oncology Center
Vinnitsa
United States4 sites
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Physicians Research Group
San Jose, California, 95124
St. Jude Hospital Yorba Linda, St. Joseph's Heritage Healthcare
Santa Rosa, California, 95403
Montefiore Medical Center
The Bronx, New York, 10461
Belarus4 sites
Brest Regional Clinical Hospital
Brest
Minsk City Clinical Oncology Dispensary
Minsk
N.N. Alexandrov National Cancer Centre of Belarus
Minsk
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk
Czechia3 sites
Masaryk Memorial Cancer Institute
Brno
University Hospital Hradec Kralove
Hradec Králové
University Hospital Olomouc, Oncology
Olomouc
Slovakia3 sites
Oncology Institute of Saint Alzbeta
Bratislava
Poko Poprad, s.r.o.
Poprad
University Hospital Trencin
Trenčín
About this study
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
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.
Read the 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.
- Being tested
- Sodium cridanimod
- Keywords
- Endometrial cancer, Recurrent or persistent endometrial carcinoma, Progesterone Receptor Negative, Sodium cridanimod, Virexxa
- Medical subject headings
- Recurrence, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium cridanimodDrug
Also called Virexxa
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium cridanimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: 12 months
Secondary outcomes (5)
Progression-free survival
Measured: 24 months
Time to response
Measured: 12 months
Time to progression
Measured: 24 months
Overall survival
Measured: 24 months
Overall Disease Control Rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Persistent Endometrial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevelt AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmasyntez
- Responsible party
- Sponsor
- Investigators
- Laura L. Douglass, Study director, Kevelt AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064725
- Sponsor's protocol ID
- VX-EC-2-2013
- Status last verified
- Jan 2017
- First submitted
- 14 Feb 2014
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02064725
- Acronym / sponsor ID
- VX-EC-2-2013
- Keywords
- Endometrial cancer, Recurrent or persistent endometrial carcinoma, Progesterone Receptor Negative, Sodium cridanimod, Virexxa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kevelt ASIndustry (pharma, biotech, devices)
- Collaborators
- Pharmasyntez
- Study start
- Sep 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium cridanimod | Experimental | Drug: Sodium cridanimodSodium 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium cridanimodAlso: VirexxaEligible 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). | Drug | Sodium cridanimod |
Primary outcome
Objective Response Rate
Time frame: 12 months
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
Related trials for Recurrent or Persistent Endometrial Carcinoma
Active, not recruitingPhase 2
Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer
Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Malignant Uterine Corpus Neoplasm
Active, not recruitingPhase 2
Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone
Endometrial Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma
Active, not recruitingPhase 2
Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment
Endometrial Adenocarcinoma, Endometrial Carcinosarcoma
RecruitingPhase 2
Study of EV for Recurrent Endometrial Carcinoma
Endometrial Cancer
Active, not recruitingPhase 2
Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer
Endometrial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura L. Douglass study director
Kevelt AS
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium cridanimod in people with Recurrent or Persistent Endometrial Carcinoma, run by Kevelt AS at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Ukraine, United States, Belarus, Czechia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.