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New treatment option for Endometrial Carcinoma
Official title Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma
ClinicalTrials.gov ID: NCT04716686
What this study is testing
What is Niraparib?
Niraparib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for endometrial carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Endometrial Serous carcinoma (ESC) has similar molecular characteristics to high-grade serous ovarian carcinoma (HGSOC) and basal cell-like breast cancer, such as similar Chromosomal instability, somatic copy number variation profiles and somatic mutations. The clinical treatment of ESC also refers to the treatment model of HGSOC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women aged 18 or above
- Histological confirmation of serous endometrial cancer or other types of endometrial cancer
- FIGO stage III-IV
- ESC Patients have received at least 6 cycles of first-line platinum containing chemotherapy after surgery and achieved CR, PR or SD; ESC patients...
- ESC Patients have received \>2 lines of platinum containing chemotherapy and relapsed; patients with other types of endometrial cancer have received...
You likely can't join if
- Allergic to active or inactive ingredients of ZL-2306 (nirapali) or drugs with similar chemical structure to ZL-2306 (nirapali)
- Stage Ia(on invasion to myometrium)
- Symptomatic, uncontrollable brain metastases or pial metastases(No imaging scan is required); patients with spinal cord compression can still be...
- Received surgery within 3 weeks before the start of the study, or any surgical effects that have not recovered.
- Received palliative radiotherapy with \>20% bone marrow 1 week before enrollment
- Suffered from other aggressive cancers (except for fully treated basal or squamous cell skin cancer) within 2 years before enrollment
See the full eligibility criteria
- Women aged 18 or above
- Histological confirmation of serous endometrial cancer or other types of endometrial cancer
- FIGO stage III-IV
- ESC Patients have received at least 6 cycles of first-line platinum containing chemotherapy after surgery and achieved CR, PR or SD; ESC patients have received platinum containing chemotherapy after the first relapse...
- ESC Patients have received \>2 lines of platinum containing chemotherapy and relapsed; patients with other types of endometrial cancer have received \>2 lines of platinum containing chemotherapy and have BRCA mutation...
- Radiotherapy or endocrine therapy history is allowed
- Cohort 1 life expectancy\> 6 months; Cohort 2 life expectancy\> 4 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Patients agreed to provide blood samples for testing BRCA status and HRR mutations.
- Patients agreed to provide formalin-fixed and paraffin-embedded tumor tissue samples for the detection of homologous recombination repair related genes (optional)
- Laboratory criteria are as follows:
- Neutrophil count ≥1500/µL;Platelets ≥100,000/µL;Hemoglobin ≥10g/dL;Serum creatinine ≤1.5 times of the upper limit, or creatinine clearance ≥60mL/min;Total bilirubin ≤1.5 times of the upper limit or direct bilirubin ≤1.0...
- Patients of reproductive potential must have a negative urinary or serum pregnancy test when done and promise to take effective contraceptive measuresduring the period of the study; Or without potential fertility...
- Women who have undergone contraceptive operation(hysterectomy, bilateral oophorectomy or bilateral salpingectomy), or
- over 60 years old, or≥40 and \<60 years of age, menopause for more than 12 months, and follicle-stimulating hormone test results are within the reference range of research institutions after menopause
- Willingness to sign a written informed consent document and follow the plan
- Any previous toxic and side effects of chemotherapy have recovered to ≤ CTCAE level 1 or baseline level, except for sensory neuropathy or hair loss with stable symptoms ≤ CTCAE level 2
- Allergic to active or inactive ingredients of ZL-2306 (nirapali) or drugs with similar chemical structure to ZL-2306 (nirapali)
- Stage Ia(on invasion to myometrium)
- Symptomatic, uncontrollable brain metastases or pial metastases(No imaging scan is required); patients with spinal cord compression can still be considered for enrollment if they have received targeted therapy and have...
- Received surgery within 3 weeks before the start of the study, or any surgical effects that have not recovered.
- Received palliative radiotherapy with \>20% bone marrow 1 week before enrollment
- Suffered from other aggressive cancers (except for fully treated basal or squamous cell skin cancer) within 2 years before enrollment
- Previously or currently diagnosed as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Suffer from serious or uncontrollable diseases, including but not limited to:
- Uncontrollable nausea and vomiting, inability to swallow drugs, any gastrointestinal diseases that may interfere with drug absorption and metabolism
- Active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.
- Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders
- Immune deficiency (except for splenectomy)
- Any past or current disease, treatment or laboratory abnormality that may interfere with the results of the study, or be defined as not suitable for this study
- Receive platelet or red blood cell transfusion within 4 weeks before the start of the study.
- Pregnant or breastfeeding, or expect to become pregnant during the study.
- Have received any PARP inhibitor treatment previously.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.