Trial of Maintenance With Niraparib- Uterine Serous Carcinoma

Launched by NORTHWELL HEALTH · Sep 3, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Niraparib for women with advanced or recurrent uterine serous carcinoma, a type of endometrial cancer that can be particularly aggressive. The goal is to see if Niraparib can help maintain the improvement in patients who have responded to their initial chemotherapy treatment. Researchers believe that this treatment might be well-tolerated and effective, which could improve outcomes for patients with this challenging condition.

To participate in the trial, women must be at least 18 years old and have a confirmed diagnosis of uterine serous carcinoma that is advanced or has come back after treatment. They should also have shown a positive response to previous chemotherapy. Participants will need to agree to certain tests and follow specific health guidelines during the study. If eligible, patients can expect close monitoring and support throughout the treatment process. It's important to note that women who are pregnant or breastfeeding cannot take part, and those with certain health conditions may not be eligible.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female, age at least 18 years
• • 2. ECOG performance status of \<2
• • 3. Written voluntary informed consent
• • 4. Histologically diagnosed Uterine Serous Carcinoma.
• • 5. Patient must agree to undergo Foundation One testing.
• • 6. Patient diagnosed with advanced stage USC including stage III, stage IV, or platinum-sensitive recurrent USC
• • 7. If recurrent USC, patient must have platinum sensitive disease after initial treatment; defined as achieving a response (CR or PR) and disease progression \>6 months after completion of their last dose of platinum chemotherapy.
• • 8. Patients eligible if receiving 1st or 2nd line chemotherapy for recurrence.
• • 9. The patient must have achieved a partial, stable, or complete tumor response following the last chemotherapy (minimal of 3 cycles) regimen of physician choice chemotherapy indicating partial, stable, complete tumor response.
• • 10. Patients must receive Niraparib maintenance within 12 weeks after completion of their final dose of chemotherapy regimen or within 14 weeks if received radiation therapy. CT Chest/Abd/Pelvis will be performed within 28 days of starting Niraparib.
• • 11. Lesions can be non-measurable or measurable by RECIST 1.1 criteria.
• 12. Adequate organ function, defined as:
• • 1. Absolute neutrophil count ≥ 1,500/μL
• • 2. Platelets ≥ 100,000/μL
• • 3. Hemoglobin ≥ 9 g/dL
• • 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
• • 5. Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
• • 6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
• • 13. Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
• • 14. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
• 15. Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non childbearing potential. Non childbearing potential is defined as follows (by other than medical reasons):
• • 1. ≥45 years of age and has not had menses for \>1 year Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 6.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
• • 2. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
• • 3. Able to take oral medications.
• Exclusion Criteria:
• • 1. Participant must not be simultaneously enrolled in any interventional clinical trial
• • 2. Drainage of ascites during the last 2 cycles of last chemotherapy
• • 3. Radiotherapy was given within 2 weeks encompassing \>20% of the bone marrow or any radiation therapy within one week prior to Day 1 of protocol therapy. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy.
• • 4. Persistent \>Grade 2 anemia, neutropenia, or thrombocytopenia from prior cancer therapy, that has persisted \> 4 weeks and was related to the most recent treatment.
• • 5. Symptomatic uncontrolled brain or leptomeningeal metastases.
• • 6. Known hypersensitivity to the components of Niraparib
• • 7. Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery
• • 8. Diagnosis, detection, or treatment of invasive cancer other than uterine cancer \</= 2 years prior to study enrollment (except basal or squamous cell carcinoma of the skin that has been definitively treated)
• • 9. Patient considered a poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection.
• • 10. Patients must not have received a transfusion within 4 weeks of the first dose of study treatment
• • 11. Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
• • 12. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
• • 13. Immunocompromised patients (splenectomy patients are allowed)
• • 14. Patients with known active hepatitis disease
• • 15. Prior treatment with a known PARP inhibitor
• • 16. Patients noted to have MSI-H mutational burden.