Trial of Maintenance With Niraparib- Uterine Serous Carcinoma
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|ClinicalTrials.gov Identifier: NCT04080284|
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : March 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Papillary Serous Endometrial Carcinoma Uterine Serous Carcinoma Endometrial Carcinoma Cancer of the Endometrium||Drug: Niraparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Niraparib maintenance treatment will be given to patients for 1 year on study or until disease progression. Patients not tolerating the treatment will stop the niraparib treatment based on criteria described below. Patients who are benefitting from treatment will have access to their assigned treatment as long as considered acceptable by their treating physician or until they are discontinued for one of the below reasons.|
|Masking:||None (Open Label)|
|Official Title:||Trial of Maintenance With Niraparib in Patients With Stage III, Stage IV or Platinum-sensitive Recurrent Uterine Serous Carcinoma|
|Actual Study Start Date :||December 30, 2019|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2025|
-Cohort - Uterine serous carcinoma
Study treatment will be administered orally Q day continuously. Up to three capsules of 100mg strength will be taken at each dose administration. Initiation dose will be defined per current FDA guidelines for Niraparib treatment in ovarian cancer. Dose interruption (no longer than 28 days) will be allowed. Dose reduction will be allowed based on treatment side effects. Dose reductions to 2 capsules daily (200mg) and subsequently to 1 capsule daily (100mg) will be allowed. No further dose reductions will be allowed. The timing of efficacy or safety evaluations should not be affected by dose interruptions or reductions.
Other Name: ZEJULA
- PFS [ Time Frame: 1 year ]To determine the Progression Free Survival (PFS) at 1 year in the proposed Niraparib regimen in the population of patients with stage III, all stage IV, or recurrent uterine serous carcinoma (USC).
- PFS [ Time Frame: 3 years ]Progression-free survival (PFS)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years ]To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in patients with stage III, all stage IV, or recurrent uterine serous carcinoma (USC).
- Mutational burden [ Time Frame: 3 years ]To identify the prevalence of somatic mutations, HRD mutations, and overall mutational burden in patients with USC and classify tumor into loss of heterozygosity (LOH) high and low phenotype.
- Quality of Life (QOL) measures using Functional Assessment of Cancer Therapy (FACT- endometrial cancer) and EQ-5D-5L Euroqol [ Time Frame: 5 years ]To evaluate quality of life (QOL) for the subjects undergoing this treatment, using validated tools. QOL will be assessed every 3 months during treatment course. [Functional Assessment of Cancer Therapy - Endometrial Cancer questionnaire (score range from 0 to 120 - Higher scores represent better quality of life. EQ-5D-5L Euroqol is scored 0-20, with negative values corresponding to death, full health, and health states worse than death
- Overall Survival [ Time Frame: 3 years ]Overall Survival
- ORR [ Time Frame: 3 years ]Overall response rate (ORR) at 2, and 3 years interval from start of treatment protocol
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): NCT04080284
|Contact: Sally Floresemail@example.com|
|Contact: Mary Agnes Templetonfirstname.lastname@example.org|
|Principal Investigator:||Marina Frimer, MD||Northwell Health|