An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03077698|
Recruitment Status : Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : September 21, 2018
This is an open-label, multi-center, single-arm, two-period Phase 2 study. The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with recurrent or persistent endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative. All patients must have endometrial cancer PrR status determined from an archival sample at Screening. The PrR status (positive or negative) will be determined by central laboratory by IHC testing.
There are two treatment periods and a follow-up period within the study.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Sodium Cridanimod Drug: progestin therapy||Phase 2|
Treatment Period 1 (Progestin Monotherapy): During Treatment Period 1, all subjects determined to be PrR positive will receive progestin monotherapy, megestrol acetate, for up to 24 weeks. Subjects will have an MRI or CT scan after 12 and 24 weeks of progestin monotherapy, with response to treatment being assessed according to RECIST 1.1 criteria. All subjects that achieve disease control confirmed by tumor assessment after Treatment Period 1, will be ineligible to enter Treatment Period 2. These subjects will be terminated from the trial and treated according to local standards of practice, which may include continued progestin therapy.
Subjects determined to be PrR negative at Screening will not enroll into Treatment Period 1. These subjects will enroll directly into Treatment Period 2.
Treatment Period 2 (Combination Treatment): All subjects determined to be PrR negative at Screening and those who received at least 4 weeks of progestin monotherapy and who experienced disease progression at the conclusion of Treatment Period 1 will enter Treatment Period 2 of the study. During Treatment Period 2, subjects will receive Sodium Cridanimod in combination with continued progestin treatment, megestrol acetate. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria, with response assessments performed at 12-week intervals.
Follow-up Period: Once subjects progress during Treatment Period 2, they will return for a Safety Follow-up Visit 4 weeks following the last treatment, and then continue to be followed for an additional 12-month period for overall survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase 2, Single Arm, Two Period Study|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Endometrial Carcinoma|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2021|
Experimental: Sodium Cridanimod & progestin therapy
Sodium Cridanimod and progestin therapy (megestrol acetate) combination
Drug: Sodium Cridanimod
The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative.
Drug: progestin therapy
The study will investigator the use of progestin therapy in conjunction with Sodium Cridanimod
Other Name: megestrol acetate
- Tumor assessment [ Time Frame: Every 12 weeks, up to 52 weeks ]MRI/CT scans will be performed at intervals during the study to assess disease control or progression
- Objective Response Rate (ORR) [ Time Frame: 24 months ]The Objective Response Rate (ORR) is defined as the proportion of subjects who achieved complete responses or partial responses during Treatment Period 2.
- Progression-free Survival (PFS) [ Time Frame: 24 months ]Progression-free Survival (PFS) is defined as the duration of time from initiation of Treatment Period 2 (Day 0) until disease progression or death from any cause, whichever occurs first.
- Duration of Stable Disease [ Time Frame: 24 months ]Duration of Stable Disease is defined as the duration of time from initiation of Treatment Period 2 (Day 0) until the criteria for disease progression are first met.
- Overall Survival (OS) [ Time Frame: 12 months ]Overall Survival (OS) is defined as the duration of time from initiation of Treatment Period 2 (Day 0) until the subject's death from any cause.
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): NCT03077698
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|Study Director:||Curtis Lockshin, PhD||Xenetic Biosciences, Inc.|