Virexxa (Sodium Cridanimod) w/Progestin Therapy in Pts w/Progesterone Receptor Neg Recurrent/Persistent Endometrial CA
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|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
|Condition or disease||Intervention/treatment||Phase|
|Recurrent or Persistent Endometrial Carcinoma||Drug: Sodium cridanimod||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Objective Response Rate [ Time Frame: 12 months ]
- 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 ]
- Progesterone receptor (PrR) levels [ Time Frame: 1 months ]
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
|Study Director:||Laura L. Douglass||Kevelt AS|